MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-12-11 for MULTI CLIP APPLIER LIGACLIP ERCA ROTATING 20 LARGE CLIPS ETHER420 manufactured by Sterilmed, Inc..
[130050373]
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. The device history record (dhr) was reviewed and there are no observed discrepancies upon review of the device history record. An event date of (b)(6) 2018 was provided with the exact date unknown. Therefore, the first day of the month was used. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[130050374]
It was reported that a (b)(6) patient underwent a laparoscopic cholecystectomy procedure with a multi clip applier ligaclip erca rotating 20 large clips and the clips became sissored. The surgeon was using the reprocessed clip applier and the clips scissored, in which the 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 used to complete the procedure. There were no patient consequences. This event has been assessed as a malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2018-00113 |
| MDR Report Key | 8152843 |
| Report Source | USER FACILITY |
| Date Received | 2018-12-11 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2019-01-23 |
| Device Manufacturer Date | 2018-06-25 |
| Date Added to Maude | 2018-12-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 9497898687 |
| Manufacturer G1 | STERILMED, INC. |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55446 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI CLIP APPLIER LIGACLIP ERCA ROTATING 20 LARGE CLIPS |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2018-12-11 |
| Returned To Mfg | 2019-01-23 |
| Catalog Number | ETHER420 |
| Lot Number | 2065057 |
| Device Expiration Date | 2019-06-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 5010 CHESHIRE PARKWAY STE 2 PLYMOUTH MN 55446 US 55446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-11 |