MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-27 for CRILE ARTERY FORCEPS (6 1/4") CURVED 105-141 manufactured by Integra York Pa, Inc. /jarritt Surgical Instruments.
[137560420]
Approximately 5mm portion of? Crile artery forceps (6?? ) curved? Clamp tip (1 tip) identified to be missing at the conclusion of the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084508 |
| MDR Report Key | 8378427 |
| Date Received | 2019-02-27 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-02-25 |
| Date Added to Maude | 2019-02-28 |
| 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 |
| 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 | CRILE ARTERY FORCEPS (6 1/4") CURVED |
| Generic Name | CRILE CLAMP |
| Product Code | GEN |
| Date Received | 2019-02-27 |
| Model Number | 105-141 |
| Catalog Number | 105-141 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK PA, INC. /JARRITT SURGICAL INSTRUMENTS |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-27 |