MAUDE Adverse Event Report: CONMED CORPORATION LAP ELEC,L-HOOK,27 CM; LAP ELECTRODES

Catalog Number 60-5163-002

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: LAP ELEC,L-HOOK,27 CM
• Type of Device: LAP ELECTRODES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 7403071
• MDR Text Key: 104709473
• Report Number: 1320894-2018-00077
• Device Sequence Number: 1
• Product Code: HFG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 60-5163-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1