SURGISTOOL Adverse Event — Malfunction (MDR 0001831750-2020-00414)
SURGISTOOL Adverse Event — Malfunction (MDR 0001831750-2020-00414) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SURGISTOOL; Generic name: STOOL, OPERATING-ROOM; Manufacturer: STRYKER MEDICAL-KALAMAZOO.
| Device | SURGISTOOL |
|---|---|
| Generic name | STOOL, OPERATING-ROOM |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Report number | 0001831750-2020-00414 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | THIS MDR IS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICE WAS EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED; THERE WAS A BROKEN/DAMAGED COMPONENT. THE DEVICE WAS REPAIRED AND RETURNED. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE. |
| Source | openFDA MAUDE (device adverse events) |
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