MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-02-06 for ETHER320 manufactured by Sterilmed, Inc..
[17222830]
It was reported that during a laparoscopic cholecystectomy, three to four clips were malformed upon use. They did not close completely. Two to three clips had been successfully fired prior to the event. The structures being fired upon were the cystic artery and cystic duct. The clips were fully advanced into the jaws when the device was fired. The device was immediately replaced. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[17498567]
Final device investigation found that the device was returned with a clip in the jaws. The clip retainer and push fork were both bent and out of position. The clip retainer was bent upwards and one of the tines on the push fork was underneath the clip retainer where it should have been on top of the clip retainer. Upon evaluation, the device was cycled, fed and produced four tear drop shaped clips. The last clip remained stuck in the jaw and was also malformed. The devices yellow tab became visible but the locking mechanism failed to engage due to the damage. The device history record was reviewed and no discrepancies were noted. As each device is visually inspected and functionally tested prior to release, no conclusion could be made as to what may have caused the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2015-00004 |
| MDR Report Key | 4491421 |
| Report Source | 05,07 |
| Date Received | 2015-02-06 |
| Date of Report | 2015-01-14 |
| Date Mfgr Received | 2015-01-14 |
| Device Manufacturer Date | 2014-10-29 |
| Date Added to Maude | 2015-02-06 |
| 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 | 2015-02-06 |
| Returned To Mfg | 2015-02-03 |
| Model Number | ETHER320 |
| Catalog Number | ETHER320 |
| Lot Number | 1803410 |
| Device Expiration Date | 2015-10-31 |
| 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 | 5010 CHESHIRE PARKWAY, SUITE 2 PLYMOUTH MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-06 |