MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-14 for TRUMPET VALVE 8571-07 manufactured by Davis & Geck.
[17798722]
While using a trumpet valve on a laparoscopic cholecystectomy for cautery, suction, and irrigation, the insulation frayed and the gallbladder was perforated. Bile leaked into the abdominal cavity. The surgeon was able to control the event and completed the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001586 |
| MDR Report Key | 12746 |
| Date Received | 1994-04-14 |
| Date of Report | 1994-04-01 |
| Date of Event | 1994-03-17 |
| Date Added to Maude | 1994-04-18 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUMPET VALVE |
| Generic Name | ENDOSCOPIC ELECTRODE SUCTION, IRRIGATION, CAUTERY |
| Product Code | FEH |
| Date Received | 1994-04-14 |
| Catalog Number | 8571-07 |
| Lot Number | 110372 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 12746 |
| Manufacturer | DAVIS & GECK |
| Manufacturer Address | DANBURY CT 06810 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-04-14 |