MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for UNIPOLAR/BIPOLAR COAGULATION 30675 ND manufactured by Karl Storz Endoscopy - America, Inc..
[123265417]
Patient procedure began and surgeon requested the storz bipolar coagulation/ dissection device. The surgeon nor the operating room tech noted anything wrong with the device. When the cautery used, the surgeon and tech noted a small amount of smoke and a few small black fragments. The surgeon removed the device, he and the operating room tech noted a small area on the instrument where the device had a break in the insulation approximately 1 cm from the tip. The surgeon then examined the patient laparoscopically again and noted a through and through burn to the patients left fallopian tube. The instrument had been cleaned and sterilized appropriately according to manufactures instructions for use. The storz instrument had been inspected prior to sterilization using the insuscan and no defects were found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080396 |
| MDR Report Key | 7946733 |
| Date Received | 2018-10-05 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-10-02 |
| Date Added to Maude | 2018-10-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | UNIPOLAR/BIPOLAR COAGULATION |
| Generic Name | COAGULATION - CUTTER, ENDOSCOPIC UNIPOLAR (AND ACCESSORIES) |
| Product Code | KNF |
| Date Received | 2018-10-05 |
| Model Number | 30675 ND |
| Catalog Number | 30675 ND |
| Lot Number | XV05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY - AMERICA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-05 |