MAUDE Adverse Event Report: CONMED CORPORATION UNIVERSAL MONOPOLAR ACTIV CORD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number SN-UAC

Device Problems Material Fragmentation (1261); Smoking (1585); Sparking (2595); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the sn-uac device was being used during a polypectomy on (b)(6) 2020 when it was reported that "during a procedure the doctor was using cautery from one of the center's bicap machines, using our active cord which was connected to a snare (microtech mfg).When the doc pressed the pedal, sparks came out of the active cord and the active cord was completely severed from the connector (the one closest to the instrument).Heat was felt and smoke was seen, and the unit was turned off, active cord was switched out and the procedure finished with no injury to the staff or to the patient." the procedure was completed with an alternate same-like device.There was no report of injury, medical intervention, or hospitalization.The current status of the patient is reported to be "as expected".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Received one sn-uac in unoriginal packaging.Lot number was not verified.Performed a visual inspection, the cord had a burned appearance and the wire inside was burned as well.The manufacturing documents from the device history record have not been reviewed because the serial number of the device was not available.The service history of the device could not be reviewed because the serial number of the device was not available.(b)(4).Per the instructions for use, the user is advised the following: contraindications: these devices should never be used when: there is visible evidence of damage to the exterior of the device such as cracked plastic or connector damage.These devices fail the inspection described here.In the presence of flammable gases, liquids, and/or oxygen enriched environments.Safety tips: never allow cables to be in contact with skin of the patient or operator during electrosurgical activations.Inspect and test each device before each use.Inspection: these devices should be inspected before and after each use.Visually examine the devices for obvious physical damage including: cracked, broken or otherwise distorted plastic parts.Broken or significantly bent connector contacts.Damage including cuts, punctures, nicks, abrasions, unusual lumps, significant discoloration.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: UNIVERSAL MONOPOLAR ACTIV CORD
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 10655569
• MDR Text Key: 211852213
• Report Number: 1320894-2020-00441
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K020186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SN-UAC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONMED BICAP III; MICROTECH SNARE