MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-16 for LAPAROSCOPIC TENACULUM 605-152 manufactured by Integra Surgical (jarit).
[114295975]
During procedure, the laparoscopic tenaculum broke. When removed, it was noted that a small screw was missing. X-ray was read as positive for foreign body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078423 |
| MDR Report Key | 7693351 |
| Date Received | 2018-07-16 |
| Date of Report | 2018-07-09 |
| Date of Event | 2018-06-21 |
| Date Added to Maude | 2018-07-17 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LAPAROSCOPIC TENACULUM |
| Generic Name | TENACULUM FORCEPS |
| Product Code | GEN |
| Date Received | 2018-07-16 |
| Model Number | 605-152 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA SURGICAL (JARIT) |
| Manufacturer Address | 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-16 |