MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-04 for LIGACLIP ETHMCS20 manufactured by Sterilmed, Inc..
[81804409]
Patient Sequence No: 1, Text Type: N, H10
[81804410]
We opened 4 reprocessed clip appliers for a thyroidectomy case. All 4 clip appliers failed to deploy accurately. Clips failed to deploy, and even fell out of the jaws before their intended use. Due to the delicate nature of the case, the clip appliers could not be relied upon to work as intended. These devices were not saved. This is not a new concern with these clip appliers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6766594 |
| MDR Report Key | 6766594 |
| Date Received | 2017-08-04 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-07-20 |
| Report Date | 2017-08-02 |
| Date Reported to FDA | 2017-08-02 |
| Date Reported to Mfgr | 2017-08-02 |
| Date Added to Maude | 2017-08-04 |
| 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 |
| 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 | LIGACLIP |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2017-08-04 |
| Catalog Number | ETHMCS20 |
| Lot Number | 171540 |
| ID Number | 7361240 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N STE 100 MAPLE GROVE MN 55369 US 55369 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-04 |