MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-10 for #002094-504 manufactured by Cabot Medical.
[16146434]
Tubal gun assembled prior to surgery and checked by surgeon. Surgeon attempted to use tubal gun resulting in laceration of left fallopian tube. Surgeon proceeded with surgery utilizing cautery. Surgeon reported that tubal gun malfunctioned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 15403 |
| MDR Report Key | 15403 |
| Date Received | 1994-01-10 |
| Date of Report | 1993-09-09 |
| Date of Event | 1993-09-07 |
| Date Facility Aware | 1993-09-07 |
| Report Date | 1993-09-09 |
| Date Reported to Mfgr | 1993-09-10 |
| Date Added to Maude | 1994-08-23 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 |
| Generic Name | FALLOPIAN RING INSTRUMENT |
| Product Code | HFJ |
| Date Received | 1994-01-10 |
| Model Number | #002094-504 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 12 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15397 |
| Manufacturer | CABOT MEDICAL |
| Manufacturer Address | 2021 CABOT BOULEVARD WEST LANGHORNE PA 19047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-01-10 |