MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for KARL STORZ 28175 UE manufactured by Karl Storz Endoscopy/america, Inc..
[11003]
Surgeon engaged bovie foot pedal for coagulation and received a slight electric shock to hand. Approximately 3-4 inches of the rubber coating on the dissecting instrument split and melted away from metal insturment. This was noticed upon removing the dissecting instrument from the port used during a laparoscopic choleystectomy procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 21131 |
| MDR Report Key | 21131 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-06-15 |
| Date of Event | 1994-06-07 |
| Date Facility Aware | 1994-06-07 |
| Report Date | 1994-06-15 |
| Date Added to Maude | 1995-04-13 |
| 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 | 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 | KARL STORZ |
| Generic Name | CAUTERY KNIFE |
| Product Code | HQR |
| Date Received | 1994-07-29 |
| Model Number | 28175 UE |
| Catalog Number | 28175 UE |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 21105 |
| Manufacturer | KARL STORZ ENDOSCOPY/AMERICA, INC. |
| Manufacturer Address | 10111 W. JEFFERSON BLVD. CULVER CA 902323578 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-07-29 |