MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-10-06 for ETHER320 ER320 manufactured by Sterilmed, Inc..
[15328373]
It was reported that the first clip came out crimped before event being placed on the vessel. Then when trying to use it again, it kept spitting out an extra clip. There was no patient injury. It was later reported that the procedure was a laparoscopic cholecystectomy. The "crimped" clip was crossed. The extra clips coming out of the device were not unformed. The issue occurred when firing over the cystic duct. There was no resistance felt when firing the device. The device was tried a second time and the clips were crossed. The device was replaced with a device from another manufacturer. The procedure was prolonged, but no time was provided.
Patient Sequence No: 1, Text Type: D, B5
[15763977]
The device has not been received at the manufacturer's facility as of the date of this report. A supplemental report will be filed after investigation if the device is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2014-00176 |
| MDR Report Key | 4152556 |
| Report Source | 05,07 |
| Date Received | 2014-10-06 |
| Date of Report | 2014-09-11 |
| Date of Event | 2014-09-08 |
| Date Mfgr Received | 2014-09-16 |
| Date Added to Maude | 2014-10-15 |
| 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 |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2014-10-06 |
| Model Number | ETHER320 |
| Catalog Number | ER320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-06 |