MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-27 for JARIT N/A B 615-152 manufactured by Integra Surgical.
[1769082]
Surgeon was using the l/s single tooth tenaculum during the laparoscopic supracervical hysterectomy procedure and the tip of the instrument fell apart. All pieces were retrieved laparoscopically. ====================== health professional's impression======================unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1862052 |
| MDR Report Key | 1862052 |
| Date Received | 2010-09-27 |
| Date of Report | 2010-09-23 |
| Date of Event | 2010-09-17 |
| Report Date | 2010-09-23 |
| Date Reported to FDA | 2010-09-27 |
| Date Added to Maude | 2010-10-08 |
| 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 | JARIT |
| Generic Name | TENACULUM |
| Product Code | HDC |
| Date Received | 2010-09-27 |
| Model Number | N/A |
| Catalog Number | B 615-152 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA SURGICAL |
| Manufacturer Address | 3498 WEST 2400 SOUTH #1050 WEST VALLEY CITY UT 84119 US 84119 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-27 |