MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-21 for MULTIPLE CLIP APPLIER LIGACLIP MCA ETHMSM20 manufactured by Sterilmed, Inc..
[111986003]
The sterilmed failure analysis lab received the device for evaluation. The analysis has begun but is not completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[111986004]
It was reported that a patient underwent a procedure with a clip appliers ligaclip multiple clip appliers lg clips and the clips did not fire correctly which caused the vessel to be severed. During the procedure, during use of the device the damage of the vessel was identified immediately. The patient? S vessel was repaired and extended hospitalization was not required. The patient has since fully recovered. The physician? S opinion on the cause of the adverse event is that it was due to product malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2018-00104 |
| MDR Report Key | 7627397 |
| Date Received | 2018-06-21 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-05-29 |
| Date Added to Maude | 2018-06-21 |
| 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 | 7634883200 |
| 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 | 0 |
| Brand Name | MULTIPLE CLIP APPLIER LIGACLIP MCA |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2018-06-21 |
| Returned To Mfg | 2018-05-31 |
| Catalog Number | ETHMSM20 |
| Lot Number | 2037507 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2018-06-21 |