200 MICRON TFL SINGLE USE FIBER Adverse Event — Malfunction (MDR 2951238-2020-00435)
200 MICRON TFL SINGLE USE FIBER Adverse Event — Malfunction (MDR 2951238-2020-00435) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 200 MICRON TFL SINGLE USE FIBER; Generic name: POWERED LASER SURGICAL INSTRUMENT; Manufacturer: GYRUS ACMI, INC.
| Device | 200 MICRON TFL SINGLE USE FIBER |
|---|---|
| Generic name | POWERED LASER SURGICAL INSTRUMENT |
| Manufacturer | GYRUS ACMI, INC |
| Report number | 2951238-2020-00435 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | User facility, Company representation |
| Narrative | THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY¿S MDR AND COMPLAINT HANDLING PROCESSES. CAPAS HAVE BEEN OPENED TO MANAGE THE ACTIONS THAT ARE BEING TAKEN TO REMEDIATE THIS ISSUE AND ENSURE ANY REQUIRED MDR REPORTING IS COMPLETED. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANU |
| Source | openFDA MAUDE (device adverse events) |
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