MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-27 for HERMAN UTERINE MANIPULATOR manufactured by Cooper Surgical.
[1790504]
Pt was having a laparoscopic procedure where surgeon was using a herman uterine manipulator. The tip of the manipulator came off without the surgeon's knowledge. The tip does not fit securely onto the handle. There was no untoward outcome for the pt, however, after examining the other herman uterine manipulator in stock that tip also did not fit securely and allowed for the tip to easily come off the handle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018736 |
| MDR Report Key | 1944048 |
| Date Received | 2010-12-27 |
| Date of Report | 2010-12-27 |
| Date of Event | 2010-12-10 |
| Date Added to Maude | 2011-01-12 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HERMAN UTERINE MANIPULATOR |
| Generic Name | UTERINE MANIPULATOR |
| Product Code | HCY |
| Date Received | 2010-12-27 |
| Lot Number | 22635 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL |
| Manufacturer Address | 15 FOREST PKWY. SHELTON CT 06484 US 06484 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-27 |