MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-04-06 for LAP ELEC,L-HOOK,27 CM 60-5163-002 manufactured by Conmed Corporation.
[104709473]
The device was discarded by the user facility; therefore, an evaluation could not be performed. The user facility could not confirm the lot number of the device that was used; therefore, the manufacturing documents from the device history record could not be reviewed. A two-year review of complaint history revealed there has been a total of 3 complaints, regarding 52 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 failure, the rate of failure would be (b)(4). Per the instructions for use, the user is advised: - inspect the insulation of the instrument shaft - do not use an instrument or electrode if the insulation is cracked, or damaged this issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[104709474]
A conmed sales representative reported on behalf of the user facility that during use of the 60-5163-002, lap elec,l-hook,27 cm, in a surgical procedure the surgeon noticed a fragment of the device had broken and fallen into the surgical site. There was a 5-minute delay in procedure while graspers were used to retrieve the fragment. This report is raised on the basis of a device malfunction with a potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2018-00077 |
| MDR Report Key | 7403071 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-06 |
| Date of Report | 2018-04-06 |
| Date Mfgr Received | 2018-03-12 |
| Date Added to Maude | 2018-04-06 |
| 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 | LAP ELEC,L-HOOK,27 CM |
| Generic Name | LAP ELECTRODES |
| Product Code | HFG |
| Date Received | 2018-04-06 |
| Catalog Number | 60-5163-002 |
| Operator | PHYSICIAN |
| 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 | 2018-04-06 |