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 2018-08-06 for REFLEX ELC,20M/L CLIPS,10/11MM 530. manufactured by Conmed Corporation.
[116380371]
The broken 530 is not expected to be returned for evaluation and review. Photographic evidence was provided but the reported failure could not be verified. This complaint of broken device is unable to be verified and a root cause cannot be determined. A two-year review of complaint history revealed there has been a total of 1 complaints, regarding 1 devices, for this device family and failure mode. During this same time frame (b)(4) devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4). It is standard medical practice to inspect medical equipment prior to use.
Patient Sequence No: 1, Text Type: N, H10
[116380372]
The sales representative reported on behalf of the customer that the 530. , reflex elc, 20m/l clips, 10/11mm, device made an audible sound while being used by the surgeon during a procedure on (b)(6) 2018. The casing to the device split open and then a small piece of plastic was seen by the team on the patient's liver. The surgeon removed the plastic piece from the patient. This event caused a 10-minute delay in the procedure. The procedure was completed as normal using an alternate device. There was no medical intervention or extended hospital stay for the patient due to this event. There was no report of injury to the user or the patient for this event. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2018-00180 |
| MDR Report Key | 7751847 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-06 |
| Date of Report | 2018-08-06 |
| Date of Event | 2018-07-12 |
| Date Mfgr Received | 2018-07-12 |
| Date Added to Maude | 2018-08-06 |
| 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 | MR. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995358 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 135025994 |
| 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 | APPLIER, HEMOSTATIC CLIP |
| Product Code | HBT |
| Date Received | 2018-08-06 |
| Catalog Number | 530. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 135025994 US 135025994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-06 |