MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-12 for MULTIPLE CLIP APPLIER LIGACLIP MCA ETHMSM20 manufactured by Sterilmed, Inc..
[141798438]
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. As such, the investigation will be closed. If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate. Since no lot number was provided, no manufacturing record evaluation review could be performed. The following report numbers are related to the same event: 2134070-2019-00124, 2134070-2019-00125, 2134070-2019-00126. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141798439]
It was reported that a patient underwent a procedure with two multi clip applier ligaclip small clips and one multiple clip applier ligaclip mca and all of the devices has scissoring clips. The devices were exchanged to complete the procedure. The intent of the procedure was not altered as a result of this event. There was no patient injury or consequence. No further information has been made available. This report is for the multiple clip applier ligaclip mca.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2019-00126 |
| MDR Report Key | 8510416 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-12 |
| Date of Report | 2019-03-20 |
| Date Mfgr Received | 2019-05-13 |
| Date Added to Maude | 2019-04-12 |
| 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 | 31 TECHNOLOGY DR |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| 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 | MULTIPLE CLIP APPLIER LIGACLIP MCA |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2019-04-12 |
| Returned To Mfg | 2019-05-13 |
| Catalog Number | ETHMSM20 |
| 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 | 2019-04-12 |