MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for ETHER420 manufactured by Sterilmed, Inc..
[127563159]
During laparoscopic cholecystectomy surgeon was using the (reprocessed) clip applier and the clips scissored (tips overlapped creating a twist), those staples were removed, the stapler was removed from the field and a new stapler (that was not processed) was opened with completion of the procedure - no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8084122 |
| MDR Report Key | 8084122 |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-11-05 |
| Report Date | 2018-11-08 |
| Date Reported to FDA | 2018-11-08 |
| Date Reported to Mfgr | 2018-11-19 |
| Date Added to Maude | 2018-11-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | NA |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2018-11-19 |
| Model Number | ETHER420 |
| Catalog Number | ETHER420 |
| Lot Number | 2065057 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 5010 CHESHIRE PKWY N STE 2 PLYMOUTH MN 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-19 |