MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-05 for SSI (HULKA TENACULUM) 52-0740 manufactured by Specialty Surgical Instrumentation, Inc..
[16112565]
Patient undergoing a laparoscopic supracervical hysterectomy. A tenaculum was inserted through the cervical os and attached to the anterior lip of the cervix. The tip broke off when the tenaculum was removed. The broken piece of the tenaculum was removed. The laparoscopy was then begun. Procedure completed without further incident. Patient taken to recovery in satisfactory condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1285692 |
| MDR Report Key | 1285692 |
| Date Received | 2009-01-05 |
| Date of Report | 2009-01-05 |
| Date of Event | 2008-11-13 |
| Report Date | 2009-01-05 |
| Date Reported to FDA | 2009-01-05 |
| Date Added to Maude | 2009-01-13 |
| 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 | 0 |
| 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 | SSI (HULKA TENACULUM) |
| Generic Name | TENACULUM, UTERINE |
| Product Code | HDC |
| Date Received | 2009-01-05 |
| Model Number | 52-0740 |
| Catalog Number | 52-0740 |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECIALTY SURGICAL INSTRUMENTATION, INC. |
| Manufacturer Address | 200 RIVER HILLS DRIVE NASHVILLE TN 37210 US 37210 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-05 |