MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for ENDOWRIST 470309 470309-14 manufactured by Intuitive Surgical, Inc..
[185051623]
Needle driver not working great during case. Then was not able to remove instrument from arm. No tissue stuck in grasper even with the "key" 1 life left manufacturer response for xi/x mega sutrecut needle driver, xi/x mega sutrecut needle driver (per site reporter). Intuitive has received the part associated with this complaint and completed investigations. Failure analysis investigations replicated/confirmed the customer reported complaint "was not able to remove instrument from arm" clarification, the instrument was found to have an input disk broken. Input disk 7 was found completely detached from the base of the housing. Improper cleaning during reprocessing most commonly causes this failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9882438 |
| MDR Report Key | 9882438 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-24 |
| Date of Event | 2019-10-28 |
| Report Date | 2020-02-24 |
| Date Reported to FDA | 2020-02-24 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOWRIST |
| Generic Name | SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT |
| Product Code | NAY |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2019-10-31 |
| Model Number | 470309 |
| Catalog Number | 470309-14 |
| Lot Number | N10190617 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTUITIVE SURGICAL, INC. |
| Manufacturer Address | 1266 KIFER ROAD SUNNYVALE CA 94086 US 94086 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |