MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-28 for HEANEY UTERINE FORCEPS GL3100 manufactured by Becton Dickinson.
[137700611]
During hysterectomy, heaney uterine forceps tip broke at the tooth, approximately 8 mm from the tip of the instrument, while attempting to grasp the uterus. The instrument was immediately removed from the field and the tip of the instrument was retrieved by the surgeon. The instrument and the broken tip were then examined by two rn? S in the room, and determined that both pieces fit firmly together with no missing pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084538 |
| MDR Report Key | 8381931 |
| Date Received | 2019-02-28 |
| Date of Report | 2019-02-28 |
| Date of Event | 2019-02-27 |
| Date Added to Maude | 2019-03-01 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEANEY UTERINE FORCEPS |
| Generic Name | CLAMP, UTERINE |
| Product Code | HGC |
| Date Received | 2019-02-28 |
| Model Number | GL3100 |
| Catalog Number | GL3100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-28 |