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 2015-12-17 for ETHER320 manufactured by Sterilmed, Inc..
[33762940]
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. The device history record could not be reviewed as a lot number was not given.
Patient Sequence No: 1, Text Type: N, H10
[33762941]
It was reported that during a procedure, the clips were coming out of the device bent, in a scissored formation. The surgeon was able to remove most of the clips that malformed. Those that could be removed without risking patient injury were cut short. It was reported that no patient injury occurred.
Patient Sequence No: 1, Text Type: D, B5
[35326660]
The device was returned to manufacturer with contaminants in the jaw area consistent with field use. As reported by the account, the device had been actuated and fired an unknown number of times. It was returned with 8 clips. The device was fired during the investigation and appeared to fire at a normal speed with the next clip loading properly into the jaws. However, the fired clips did not have the proper pinch or alignment due to the jaws being misaligned. The account complaint has been confirmed however unable to determine if the device was sent out in this condition. The device had been used and the damage may have been due to closing over a hard object or placing stress on the jaws causing them to become distorted. As device was used, no conclusion as to the root cause for this failure could be determined. The device history report was reviewed and no discrepancies were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2015-00056 |
| MDR Report Key | 5306654 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-12-17 |
| Date of Report | 2015-11-25 |
| Date Mfgr Received | 2016-01-07 |
| Date Added to Maude | 2015-12-17 |
| 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 | JASON ANDERSON |
| Manufacturer Street | 5010 CHESHIRE PARKWAY STE 2 |
| 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 | 2015-12-17 |
| Returned To Mfg | 2016-01-07 |
| Model Number | ETHER320 |
| Catalog Number | ETHER320 |
| 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 | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-17 |