MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-01-13 for ETHMCL20 manufactured by Sterilmed, Inc..
[5377663]
It was reported that during an excision abdominal wall mass, the clips would not completely close. Another device was used to complete the procedure. The device was fired "a couple of times" later outside of the patient, and the clips were tear drop shaped. There was no patient injury. Additional information was requested, but no additional information was received. A supplemental report will be sent if additional information becomes available.
Patient Sequence No: 1, Text Type: D, B5
[12875760]
Final device investigation found that the device was returned with one remaining clip in the jaw. Four tear drop shaped clips were returned with the device. The device was originally sent out with 17 clips. Upon device evaluation, it was found that the remaining clip would not fire as the locking mechanism was engaged. It appeared that the locking mechanism locked out prematurely due to possible damage to the firing mechanism. The push fork was not in position but was retracted back in the shaft and had no contact with the clip, causing the last clip not to fire. The device history record was reviewed and no discrepancies were noted. As each device is inspected and test fired 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 | 2134070-2015-00002 |
| MDR Report Key | 4413164 |
| Report Source | 05,07 |
| Date Received | 2015-01-13 |
| Date of Report | 2014-12-15 |
| Date of Event | 2014-12-04 |
| Date Mfgr Received | 2014-12-15 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2015-01-13 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA KAUFMAN |
| Manufacturer Street | 5010 CHESHIRE PWY, SUITE 2 PLYMOUTH, MN |
| Manufacturer City | 11400 73RD AVE. 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| 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 | 2015-01-13 |
| Returned To Mfg | 2015-01-05 |
| Model Number | ETHMCL20 |
| Catalog Number | ETHMCL20 |
| Lot Number | 1766592 |
| Device Expiration Date | 2015-05-31 |
| 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 PWY, SUITE 2 PLYMOUTH MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-13 |