MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-18 for WECK STAINLESS INSTRUMENT N/A 754125 manufactured by Weck.
[21080661]
Hulka tenaculum was inserted by surgeon for uterine manipulation during laparoscopic tubal ligation procedure. During procedure, tip of hulka tenaculum was seen on video screen protruding through uterine wall. Uterus was described as "spongy", "like she'd just had a baby". Perforation was immedately cauterized by surgeon. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: other, invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8229 |
| MDR Report Key | 8229 |
| Date Received | 1994-07-18 |
| Date of Event | 1993-12-30 |
| Date Facility Aware | 1994-01-10 |
| Date Reported to Mfgr | 1994-01-20 |
| Date Added to Maude | 1994-08-02 |
| 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 STAINLESS INSTRUMENT |
| Generic Name | HULKA TENACULUM - SINGLE TOOTHED |
| Product Code | HDC |
| Date Received | 1994-07-18 |
| Model Number | N/A |
| Catalog Number | 754125 |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 7904 |
| Manufacturer | WECK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-18 |