MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2018-06-05 for REFLEX ELC,20M/L CLIPS,10/11MM 530 manufactured by Conmed Corporation.
[110042265]
The reported device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.
Patient Sequence No: 1, Text Type: N, H10
[110042266]
The distributor reported on behalf of the user facility that during pre-op testing, the clip on the 530 clip applier would fall off from the jaw. The procedure was completed with an alternate device and no surgical delays. This defect was found prior to surgery, so there was no patient contact. This report is being raised on the basis of a reported malfunction with potential for injury with recurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2018-00137 |
| MDR Report Key | 7568507 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2018-06-05 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-02-21 |
| Date Mfgr Received | 2018-06-12 |
| Device Manufacturer Date | 2017-07-12 |
| Date Added to Maude | 2018-06-05 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MARTHA CAMACHO URRIBARRI |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243051 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFLEX ELC,20M/L CLIPS,10/11MM |
| Generic Name | IMAGYN CLIP APPLIERS |
| Product Code | HBT |
| Date Received | 2018-06-05 |
| Returned To Mfg | 2018-06-05 |
| Catalog Number | 530 |
| Lot Number | 201707121 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-05 |