MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-10-07 for ETHMCL20 manufactured by Sterilmed, Inc..
[27809310]
The device was not returned to the manufacturer as of the date of this report. A supplemental report will be sent after the device evaluation if the device is received.
Patient Sequence No: 1, Text Type: N, H10
[27809311]
It was reported that during a procedure the clip applier kept firing clips after the clip was applied. It was reported that there was no injury or consequence to the patient. A request for additional information was sent but no further information was available.
Patient Sequence No: 1, Text Type: D, B5
[30057204]
The device was returned in a condition consistent with use in the field. The clip retainer was missing off of the clip applier. This results in the clip applier firing unformed clips from the shaft instead of leading the clip into the jaws for proper positioning and shaping. The device was returned with 12 of 17 original clips present, the clip retained moved out of position during use in the field.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2015-00048 |
| MDR Report Key | 5131904 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-10-07 |
| Date of Report | 2015-10-30 |
| Date of Event | 2015-09-09 |
| Date Mfgr Received | 2015-10-30 |
| Device Manufacturer Date | 2015-04-22 |
| Date Added to Maude | 2015-10-07 |
| 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 | JAY ANDERSON |
| Manufacturer Street | 5010 CHESHIRE PARKWAY |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2015-10-07 |
| Model Number | ETHMCL20 |
| Catalog Number | ETHMCL20 |
| Lot Number | 1854941 |
| Device Expiration Date | 2016-04-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-07 |