MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-24 for * 19-5505 manufactured by Codman & Shurtleff, Inc..
[4728018]
Dr said clamp tip was breaking while in use in vagina, though uterus was already out of patient. Then she took out clamp and tip that broke off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4027114 |
| MDR Report Key | 4027114 |
| Date Received | 2014-07-24 |
| Date of Report | 2014-07-24 |
| Date of Event | 2014-06-02 |
| Report Date | 2014-07-24 |
| Date Reported to FDA | 2014-07-24 |
| Date Reported to Mfgr | 2014-08-21 |
| Date Added to Maude | 2014-08-21 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | FORCEPS |
| Product Code | HCZ |
| Date Received | 2014-07-24 |
| Model Number | 19-5505 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-24 |