MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-11-10 for HULKA FALLOPIAN CLIP APPLICATOR 8388.84 manufactured by Richard Wolf Gmbh.
[3600]
The device would not push the metal spring of a fallopian tube clip into place. The clip was discarded and another was placed with no apparent problem. The applicator was inspected at this distributor's plant and was found to have a bent shaft and a bent upper closure rod. No specific cause of the problem has been determined. Device 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. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: none or unknown. Results of evaluation: component failure. Conclusion: device failure directly caused 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 | 1418479-1993-09001 |
| MDR Report Key | 7104 |
| Date Received | 1993-11-10 |
| Date of Report | 1993-09-15 |
| Date of Event | 1993-08-12 |
| Date Facility Aware | 1993-08-19 |
| Report Date | 1993-09-15 |
| Date Reported to FDA | 1993-09-15 |
| Date Reported to Mfgr | 1993-09-15 |
| Date Added to Maude | 1993-12-09 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HULKA FALLOPIAN CLIP APPLICATOR |
| Generic Name | FALLOPIAN CLIP APPLICATOR |
| Product Code | HGD |
| Date Received | 1993-11-10 |
| Model Number | 8388.84 |
| Catalog Number | 8388.84 |
| Lot Number | 135U3 |
| ID Number | PMA NO. 870080 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 6786 |
| Manufacturer | RICHARD WOLF GMBH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-11-10 |