MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for EPIX? UNIVERSAL CLIP APPLIER CA500 manufactured by Applied Medical Resources Corporation.
[175065257]
During a laparoscopic cholecystectomy, two clip appliers were opened and "misfires" were experienced on each device. Misfires meaning the clips did not apply when the device was activated by the surgeon. Applied medical-epix universal clip applier; ref #(b)(4) lot#-1365516 expires 08-07-2022.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9590768 |
| MDR Report Key | 9590768 |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-26 |
| Date of Event | 2019-12-19 |
| Report Date | 2019-12-26 |
| Date Reported to FDA | 2019-12-26 |
| Date Reported to Mfgr | 2020-01-15 |
| Date Added to Maude | 2020-01-15 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | EPIX? UNIVERSAL CLIP APPLIER |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Product Code | MDM |
| Date Received | 2020-01-15 |
| Model Number | CA500 |
| Catalog Number | CA500 |
| Lot Number | 1365516 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES CORPORATION |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |