MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-11 for WECK HYSTEROSCOPY SCISSORS 150830 UNKNOWN manufactured by Linvatec.
[20159891]
A piece of scissor broke off while instrument being used. Device not labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: other. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9084 |
| MDR Report Key | 9084 |
| Date Received | 1994-08-11 |
| Date of Event | 1993-11-05 |
| Date Facility Aware | 1993-11-05 |
| Date Added to Maude | 1994-11-28 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WECK HYSTEROSCOPY SCISSORS |
| Generic Name | SCISSORS |
| Product Code | HRR |
| Date Received | 1994-08-11 |
| Model Number | 150830 |
| Catalog Number | UNKNOWN |
| Lot Number | N/A |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 8744 |
| Manufacturer | LINVATEC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-08-11 |