MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2015-03-12 for ETHER320 manufactured by Sterilmed, Inc..
[20749469]
It was reported that the clips would not close enough to hold on to tissue. The clip did not form correctly. Clips kept falling off. Another device was opened to complete the surgery. There was no patient injury or delay. Additional information was requested, but no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[21073810]
Final device investigation found that the device was returned in good visual condition with a clip present in the jaw. The handle and shaft were visually acceptable, and the jaw appeared in alignment. The clip retainer, push fork and jaw clearance were also acceptable. Upon functional evaluation, the remaining nine clips were cycled, fed and produced with proper alignment and pinch. After the last clip was fired, the locking mechanism engaged as intended. No lot number was provided, so the device history record could not be reviewed for discrepancies. As the device operated as intended during evaluation, no conclusion could be made as to what may have caused the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2015-00009 |
| MDR Report Key | 4596485 |
| Report Source | 00,05 |
| Date Received | 2015-03-12 |
| Date of Report | 2015-02-12 |
| Date of Event | 2015-02-10 |
| Date Mfgr Received | 2015-02-12 |
| Date Added to Maude | 2015-03-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA KAUFMAN |
| Manufacturer Street | 5010 CHESHIRE PARKWAY, SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888321 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2015-03-12 |
| Returned To Mfg | 2015-02-27 |
| Model Number | ETHER320 |
| Catalog Number | ETHER320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GRV MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-12 |