MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-04-20 for ETHMCM20 manufactured by Sterilmed, Inc..
[16888740]
It was reported that when an attempt was made to use the device on a patient, no clips loaded and the device had no clips in it. Another device was used to complete the procedure. There was no patient injury and no change to the intent of the procedure. This report is being filed for the findings upon investigation that a missing piece was not returned with the device.
Patient Sequence No: 1, Text Type: D, B5
[17169819]
The device was returned to the manufacturer with the clear plastic sheath on the shaft of the device broken and missing approximately 1 cm of its tip near the device jaws. The plastic tip was not returned with the device. There were no remaining clips in the device. Upon evaluation, it was found that the locking mechanism was not engaged. The clip retainer and push fork were present and in position. Without the sheath being complete, there was nothing stopping the clips in the shaft from being expelled. 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 | 2134070-2015-00017 |
| MDR Report Key | 4707744 |
| Report Source | 05,07 |
| Date Received | 2015-04-20 |
| Date of Report | 2015-04-10 |
| Date of Event | 2015-01-26 |
| Date Mfgr Received | 2015-04-10 |
| Device Manufacturer Date | 2014-09-15 |
| Date Added to Maude | 2015-04-20 |
| 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 | 2015-04-20 |
| Returned To Mfg | 2015-04-01 |
| Model Number | ETHMCM20 |
| Catalog Number | ETHMCM20 |
| Lot Number | 1800657 |
| Device Expiration Date | 2015-09-30 |
| 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 | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-20 |