MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for MONOPOLAR DISSECTING HOOK CAUTERY 37470DL manufactured by Karl Storz Gmbh & Co. Kg.
[185521295]
While using laproscopic hook cautery, an area that was not intended to be cauterized was in fact cauterized. Exposed metal was noted in the instrument shaft. The site was observed and no further action was taken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9896898 |
| MDR Report Key | 9896898 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-19 |
| Report Date | 2020-03-12 |
| Date Reported to FDA | 2020-03-12 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOPOLAR DISSECTING HOOK CAUTERY |
| Generic Name | COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES) |
| Product Code | KNF |
| Date Received | 2020-03-30 |
| Model Number | 37470DL |
| Catalog Number | 37470DL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-30 |