MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-04-04 for REFLEX ELC,20M/L CLIPS,10/11MM 530. manufactured by Conmed Corporation.
[104746316]
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
[104746317]
The conmed sales representative reported on behalf of the user facility that prior to use, the 530. Clips appeared loose and during pre-op testing they failed to close successfully. The procedure was completed with another 530. Device, with a few minutes of surgical delay and no further incident. No patient injury reported. Although this failure was found pre-operational, this report is being raised on the basis of a malfunction whose recurrence has the potential for patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2018-00084 |
| MDR Report Key | 7396127 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-04 |
| Date of Report | 2018-05-04 |
| Date of Event | 2018-03-12 |
| Date Mfgr Received | 2018-05-04 |
| Device Manufacturer Date | 2017-10-02 |
| Date Added to Maude | 2018-04-04 |
| 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 | 2018-04-04 |
| Returned To Mfg | 2018-04-19 |
| Catalog Number | 530. |
| Lot Number | 201710021 |
| 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 | 2018-04-04 |