MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-01-08 for HEANEY-BALLENTINE HYSTERECTOMY FORCEPS, 8 1/4", C 505-320 manufactured by .
[1037238]
The user facility reported that the tip broke off a heaney-ballentine hysterectomy forcep during a hysterectomy procedure. An x-ray was taken and the broken tip was removed. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8164649]
To date the device involved in the reported incident has not yet been received for evaluation. An investigation has been initiated based on the reported information. Integra lifesciences corporation is filing on behalf of the initial distributor j. Jamner surgical instruments.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2430952-2009-00001 |
| MDR Report Key | 1316770 |
| Report Source | 05 |
| Date Received | 2009-01-08 |
| Date of Report | 2008-01-08 |
| Date Facility Aware | 2008-12-30 |
| Report Date | 2008-01-07 |
| Date Mfgr Received | 2008-12-30 |
| Date Added to Maude | 2009-12-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | SANDRA LEE, RN, BSM |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEANEY-BALLENTINE HYSTERECTOMY FORCEPS, 8 1/4", C |
| Generic Name | JARIT OBSTETRICS/GYNECOLOGY |
| Product Code | HCZ |
| Date Received | 2009-01-08 |
| Catalog Number | 505-320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-08 |