MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-25 for ENDOCOAGULATOR 30627PA manufactured by Karl Storz Endoscopy-america, Inc..
[10003]
Upon completion of case, a blanched area was noted on the top portion of the utero-sacral ligament due to malfunction of endo coagulation probe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004860 |
| MDR Report Key | 19125 |
| Date Received | 1995-01-25 |
| Date of Report | 1995-01-09 |
| Date of Event | 1995-01-06 |
| Date Added to Maude | 1995-01-26 |
| 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 | ENDOCOAGULATOR |
| Generic Name | SEMM POINT COAGULATOR |
| Product Code | FEH |
| Date Received | 1995-01-25 |
| Model Number | 30627PA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19049 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | CULVER CITY CA 902323578 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 1995-01-25 |