IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4 Adverse Event — Malfunction (MDR 1045254-2020-00245)
IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4 Adverse Event — Malfunction (MDR 1045254-2020-00245) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4; Generic name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP; Manufacturer: MEDTRONIC
| Device | IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4 |
|---|---|
| Generic name | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDP |
| Manufacturer | MEDTRONIC XOMED INC. |
| Report number | 1045254-2020-00245 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | H3 THE PRODUCT ANALYSIS RESULT COULD NOT VERIFY OVERHEATING. THE HANDPIECE WAS UNABLE TO RUN DUE TO MOTOR CORRODED AND DAMAGED HOUSING. H6: ADDITIONAL INFORMATION SUGGEST THAT FDM 4118 , FDR 3233 AND FDC 11 ARE NO LONGER APPLICABLE TO THIS EVENT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED |
| Source | openFDA MAUDE (device adverse events) |
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