MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-10-27 for ETHER420 ER420 manufactured by Sterilmed, Inc..
[5001661]
It was reported that upon the first firing and for all subsequent firings of the device the clip tips did not meet but crossed deploying an incorrect tip alignment. A second device also had the same issue. There was no pt injury. It was later reported that the devices had been fired on a small vessel. Small vessel bleeding was reported. A third device from another mfr was used to complete the case. No cholangiogram was performed on the procedure. There was no torquing or twisting of the device present at the time of firing. The clips was fully advanced into the jaws prior to firing, and a clip could be visualized in the jaws prior to firing. There were no feeding issues experienced. The clips were not fired over another clip or hard structure. This report is being filed for the second device. See related mfr report #: 2134070-2014-00183.
Patient Sequence No: 1, Text Type: D, B5
[12602101]
Final device eval found that the device was returned in good visual condition. Upon evaluation, the handle and shaft were visually acceptable. The jaw appeared to be in alignment and the clip retainer, push fork and jaw clearance were acceptable. The device was then cycled, fed and produced the eight remaining clips with proper pinch and alignment. After the last clip was fired, the locking mechanism engaged as intended. The device history record was reviewed, and no discrepancies were noted. As the device operated as intended during eval, no conclusion could be made as to what may have caused the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2014-00182 |
| MDR Report Key | 4224526 |
| Report Source | 05,07 |
| Date Received | 2014-10-27 |
| Date of Report | 2014-10-01 |
| Date of Event | 2014-10-01 |
| Date Mfgr Received | 2014-10-01 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2014-11-18 |
| 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 | TRICIA SCHRATER |
| Manufacturer Street | 11400 73RD AVE. NORTH |
| Manufacturer City | MAPLE GROVE MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7634883211 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2014-10-27 |
| Returned To Mfg | 2014-10-13 |
| Model Number | ETHER420 |
| Catalog Number | ER420 |
| Lot Number | 1781847 |
| Device Expiration Date | 2015-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-27 |