MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-13 for BABCOCK FORCEPS, ROTO-LOK, RATCHET, 5MM, 32CM * 625-147 manufactured by Koscher & Wurtz Gmbh.
[456399]
During a laparoscopic procedure, the device was being used inside of a patient and the lower jaw of instrument fell off in patient's abdomen. The doctor was able to remove the broken piece of device from the patient abdomen. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2006-00016 |
| MDR Report Key | 699887 |
| Date Received | 2006-04-13 |
| Date of Report | 2006-04-13 |
| Date Facility Aware | 2006-03-17 |
| Report Date | 2006-04-13 |
| Date Reported to FDA | 2006-04-13 |
| Date Added to Maude | 2006-04-18 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | BABCOCK FORCEPS, ROTO-LOK, RATCHET, 5MM, 32CM |
| Generic Name | JARIT ENDOSCOPIC INSTRUMENTS |
| Product Code | HCZ |
| Date Received | 2006-04-13 |
| Model Number | * |
| Catalog Number | 625-147 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 688976 |
| Manufacturer | KOSCHER & WURTZ GMBH |
| Manufacturer Address | * * GM |
| Baseline Brand Name | BABCOCK FORCEPS, ROTO-LOK, RATCHET, 5MM, 32CM |
| Baseline Generic Name | JARIT ENDOSCOPIC INSTRUMENTS |
| Baseline Model No | * |
| Baseline Catalog No | 625-147 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-04-13 |