MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-03-09 for REFLEX ELC,20M/L CLIPS,10/11MM 530 manufactured by Conmed Corporation.
[102069323]
The used device was returned to conmed with original opened product packaging. Upon visual inspection, five clips were observed within the device shaft. The device was activated five times and all five clips were dispensed from the device during use testing. When the clips were loaded into the jaws of the device, gaps were observed between the jaws and the clips. Three of the five clips were observed to fall out of the jaws with little to no agitation to the device. Two of the clips were observed to stay within the jaws, however; still appeared loose. The reported issue was verified and likely causes for this defect are damage to the device or a manufacturing issue. A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications. Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture. A two-year review of complaint history revealed no other similar complaints for this product family and failure mode. In that same timeframe, (b)(4) units of this product family have been sold worldwide, making the rate of occurrence of this confirmed failure (b)(4) percent. A risk analysis was performed and found this failure mode and occurrence level to be consistent with current risk documents. The clinical data report for this device states that, when used under the conditions and purposes intended by the manufacturer, the undesirable side effects, under normal conditions of use, are acceptable when weighed against the benefits to patients. The instructions for use advise the user of the following. - always check to see that a clip is in the jaws before squeezing the trigger. - closing of empty jaws on tissue may cause tissue damage. - always ensure trigger is squeezed completely and allowed to open to fill initial position. Due to the severity of this reported patient injury, an investigation has been initiated. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[102069324]
The conmed sales representative reported on behalf of an user facility that during a laparoscopic heminephrectomy, during control of the secondary renal artery, the 530 clip applier's clip did not close and fell. This contributed to the break of an artery. The fallen clip was retrieved with forceps and the bleeding from the damaged artery was controlled with hemolock clips. The procedure was completed using hemolock clips with a procedural delay of 15 minutes. Upon gathering additional information, the patient did not require additional interventions post procedure or additional hospital stay. This report is raised on the basis of a reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2018-00048 |
| MDR Report Key | 7328463 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-09 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-02-09 |
| Device Manufacturer Date | 2017-08-14 |
| Date Added to Maude | 2018-03-09 |
| 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 | 2018-03-09 |
| Returned To Mfg | 2018-03-05 |
| Catalog Number | 530 |
| Lot Number | 201708141 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Other | 2018-03-09 |