MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-29 for ETHER320 manufactured by Sterilmed, Inc..
[61084679]
The device has not yet been returned to the manufacturer at the time of this report. A supplemental form will be sent once the evaluation is completed if the device is returned. The device history report was not able to be reviewed as no lot number was given.
Patient Sequence No: 1, Text Type: N, H10
[61084680]
It was reported that the device misfired during a case. No patient injury or consequences were reported. Additional information request received in a photo of the malformed clip in a tear drop shape with double clips formed together.
Patient Sequence No: 1, Text Type: D, B5
[63726598]
The clip applier was returned with only a single clip remaining which was present in the jaws. The device was fired and the single clip that was produced before the locking mechanism engaged displayed the proper pinch and alignment. Based on this evidence the account's complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2016-00087 |
| MDR Report Key | 6132879 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-29 |
| Date of Report | 2016-11-08 |
| Date of Event | 2016-11-04 |
| Date Mfgr Received | 2016-12-22 |
| Date Added to Maude | 2016-11-29 |
| 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 SUITE 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 | 2016-11-29 |
| Returned To Mfg | 2016-12-22 |
| Model Number | ETHER320 |
| Catalog Number | ETHER320 |
| 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 | 2016-11-29 |