MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-07 for JARIT TENACULUM FORCEPS * manufactured by Integra Jarit Instruments.
[1955076]
Patient underwent a robot-assisted laparoscopic hysterectomy. Surgery itself was uneventful. After completion of surgery and during equipment check it was noted that a small pin (about 5 mm in length) was missing from the end of the laparoscopic tenaculum. It was the pin that holds the pincers of the instrument together. The surgical tech and assistant surgeon were interviewed. The main surgeon was at the console and not involved using the tenaculum. The assistant surgeon stated he cannot remember if the instrument was intact after he withdrew from the patient (the room was darkened) but feels it was in proper working condition. The surgical tech was less certain that it was intact after usage. Therefore the assumption is that the pin was possibly retained by the patient. If the pin was retained the surgeon felt that it was too small to be identifiable by radiology and unsafe to try and retrieve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2026934 |
| MDR Report Key | 2026934 |
| Date Received | 2011-03-07 |
| Date of Report | 2011-03-07 |
| Date of Event | 2011-02-11 |
| Report Date | 2011-03-07 |
| Date Reported to FDA | 2011-03-07 |
| Date Added to Maude | 2011-03-22 |
| 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 TENACULUM FORCEPS |
| Generic Name | TENACULUM FORCEPS |
| Product Code | HDC |
| Date Received | 2011-03-07 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA JARIT INSTRUMENTS |
| Manufacturer Address | 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-07 |