MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-12-14 for STEINER MORCELLATOR MOTOR 20712070 manufactured by Karl Storz.
[16614025]
While using a morcellator and endocath during nephrectomy procedure, the morcellator ruptured the wall of the endocath and caused a bowel injury. The pt required an emergency bowel resection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 254924 |
| MDR Report Key | 254924 |
| Date Received | 1999-12-14 |
| Date of Report | 1999-12-08 |
| Date of Event | 1999-11-24 |
| Date Facility Aware | 1999-11-29 |
| Report Date | 1999-12-08 |
| Date Reported to Mfgr | 1999-12-08 |
| Date Added to Maude | 1999-12-21 |
| 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 | STEINER MORCELLATOR |
| Generic Name | MORCELLATOR AND ENDOCATH |
| Product Code | LEC |
| Date Received | 1999-12-14 |
| Model Number | MOTOR 20712070 |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 246852 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | 600 CORPORATE POINT CULVER CITY CA 902307600 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 15 | 1. Required No Informationntervention | 1999-12-14 |