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..
[5497000]
It was reported that the product jammed upon use. Another device was opened. There was no patient injury. This case is being reported for the findings upon investigation.
Patient Sequence No: 1, Text Type: D, B5
[12965911]
Final device investigation found that the device was returned with a clip in the jaws and the clip retainer bent, out of position and detached on one side. Upon evaluation, the device was fired. The closing jaws further damaged the clip retainer while producing a tear drop shaped clip. The retainer was damaged further when the next clip was loaded into the jaws. When actuated a second time, the loaded clip fired unformed and the clip retainer fully separated from the distal tip of the device. No further actuation produced any further clips. 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 | 2134070-2015-00005 |
| MDR Report Key | 4491458 |
| Report Source | 05,07 |
| Date Received | 2015-02-06 |
| Date of Report | 2014-10-01 |
| Date of Event | 2014-10-01 |
| Date Mfgr Received | 2015-02-06 |
| Device Manufacturer Date | 2014-07-22 |
| 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 |
| 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 | 2014-10-13 |
| Model Number | ETHER320 |
| Catalog Number | ETHER320 |
| Lot Number | 1787483 |
| Device Expiration Date | 2015-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 |