MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-03-16 for ETHER320 manufactured by Sterilmed, Inc..
[5628701]
It was reported that the clips were jamming. Another device was used to complete the procedure. There was no patient injury. This report is being filed for the findings upon product investigation. Additional information was requested, but no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[12978890]
Final device evaluation found that the device was returned with two clips in the jaws, which were out of proper aperture. One clip was improperly pinched in a tear drop shape and the other was unformed. The improperly pinched clip did not properly exit the jaws as the second unformed clip entered. This appeared to result in the second clip striking the still present partially formed clip and jamming the partially formed clip sideways in the jaws, which forced the jaws open past their proper aperture. After striking the first clip, the unformed clip turned sideways and remained in the jaws. The two clips were removed and it was noted that one jaw had a scratched and gouged edge. The jaw returned to proper alignment and aperture, and the push fork and jaw clearance were acceptable after removal of the clips. The remaining three clips were then cycled, fed and produced with proper pinch and alignment. 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. The instructions for use state "failure to fully squeeze the handles can result in an improper formation of clips," "the multiple clip applier should be fully squeezed on each firing" and "ensure full release of the trigger after firing. A partial release of the trigger restricts the clip from reaching the correct distal point in the instrument jaws, and may result in clip malformation. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2015-00010 |
| MDR Report Key | 4606182 |
| Report Source | 05,07 |
| Date Received | 2015-03-16 |
| Date of Report | 2014-11-17 |
| Date Mfgr Received | 2015-03-05 |
| Date Added to Maude | 2015-03-16 |
| 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 | 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 | 2015-03-16 |
| Returned To Mfg | 2015-03-05 |
| 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 | 2015-03-16 |