MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for ENDOWRIST 470205 manufactured by Intuitive Surgical, Inc..
[185503489]
During the case - stopped grasping tissue. Manufacturer response for fenestrated bipolar forcep, fenestrated bipolar forcep (per site reporter). The housing was removed for inspection and the instrument was found to have an input disk broken, likely causing the grip failures. Input disk#7 was found broken into pieces inside of the housing. Improper cleaning during reprocessing most commonly causes this failure. The instrument had 2 uses remaining.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9897195 |
| MDR Report Key | 9897195 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-02 |
| Date of Event | 2019-12-20 |
| Report Date | 2020-03-02 |
| Date Reported to FDA | 2020-03-02 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | 2020-03-30 |
| Returned To Mfg | 2020-01-30 |
| Model Number | 470205 |
| Catalog Number | 470205 |
| Lot Number | N111906260915 |
| 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 | 2020-03-30 |