Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: d...
Reason for Recall / Hazard
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Product Description & Identification
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A
Affected Products
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: N/A
Additional Source Details
| Field | Value |
|---|---|
| City | Sunnyvale |
| State | CA |
| Event id | 98383 |
| Address 1 | 1266 Kifer Rd |
| Code info | Lot Code: 420179: Monopolar Curved Scissors (Hot Shears) GTIN: 00886874111505 FDA Medical Device Number: D088920 Material Number: 420179-10 Batch / System Numbers: M10101102 SH0935 M10101201 SH0935 M10101202 SH1279 M10101203 SH0059 M10101204 USG294 M10101206 USG294 M10101206 SH1378 M10101214 USG022 M10101214 SH0035 M10101214 SH0495 M10110104 SH1279 M10110111 SH1378 M10110112 USG294 M10110113 SH0075 M10110121 SG704 M10110121 SH1279 M10110124 SH0495 M10110126 USG721 M10110126 SH1391 M10110127 USG721 M10110127 SH1279 M10110127 SH2144 M10110202 USG294 M10110202 SH0495 M10110203 SH2144 M10110208 SG704 M10110210 SH1378 M10110216 SH1368 M10110216 USG294 M10110216 SH1391 M10110217 SH0495 M10110217 SH1279 M10110222 SH1279 M10110228 SH0547 M10110228 USG721 M10110228 USG022 M10110228 SH1378 M10110228 SH1279 M10110301 SH1279 M10110303 SH0495 M10110304 USG294 M10110304 SH0729 M10110304 SH0761 M10110307 USG294 M10110308 USG294 M10110308 SH0035 M10110308 SH0495 M10110308 SH1279 M10110311 USG294 M10... [TRUNCATED] |
| Postal code | 94086-5304 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 86904 |
| Reason for recall | Due to increased complaints for broken/frayed grip cables for reusable instruments. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251209 |
| Initial firm notification | Letter |
| Center classification date | 20260330 |
Overview
- Recalling FirmIntuitive Surgical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - U.S. Nationwide distribution in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA and WI. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.