MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-25 for JULIET RECEIVING FORCEPS, CURVED RIGHT, 5MM, 32CM * 600-269 manufactured by Tontarra Medizintechnik.
[805966]
The distributor reported on behalf of the user facility that thirty (30) minutes after starting a laparoscopic assisted vaginal hysterectomy procedure, the tip of the forceps broke. The tip was retrieved and an x-ray was completed at the facility in order to confirm whether other broken parts had remained inside the pt. The x-ray photo could not confirm any remant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2008-00001 |
| MDR Report Key | 988963 |
| Date Received | 2008-01-25 |
| Date of Report | 2008-01-25 |
| Date Facility Aware | 2008-01-15 |
| Report Date | 2008-01-25 |
| Date Added to Maude | 2008-01-31 |
| 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 | JULIET RECEIVING FORCEPS, CURVED RIGHT, 5MM, 32CM |
| Generic Name | FORCEPS |
| Product Code | HCZ |
| Date Received | 2008-01-25 |
| Model Number | * |
| Catalog Number | 600-269 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 956826 |
| Manufacturer | TONTARRA MEDIZINTECHNIK |
| Manufacturer Address | * WURMLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-25 |