MAUDE Adverse Event Report: CONMED UTICA LINVATEC H/C LIGHTWAVE ABLATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	IA-2379
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The distributor reported on behalf of their customer that the ia-2379, linvatec h/c lightwave ablator, was being used during a video arthroscopy procedure on (b)(6) 2022 when it was reported, ¿surgery was in progress and radiofrequency was working normally, and after approx.Twenty minutes began to ring, without pressing the button.The circulator in the room had to turn off the device to prevent further damage.¿ there was no report of medical intervention or hospitalization for the patient.The procedure was completed with another ia-2379 device which caused a 20-minute delay in the procedure.Further assessment questioning found that the term ¿ring¿ said in the initial report was meant to say ¿run¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Complaint laboratory evaluation of the returned device as tested with the aes-1 generator could not confirm the reported problem; no auto-activation and no improper activation was observed during testing.Probe appears to be used due to slight wear of the active tip and appearance of blood on the handle at the point entrance of the shaft.Inspection reveals a potential saline entry point at the junction of the probe shaft and the handle and shaft bonding to the probe sleeve component internal to the handle.Upon disassembly of the probe handle, there appears to be evidence of saline residue on the switch board.The saline may have entered at the junction of the probe shaft and handle bond point.The saline appears to have entered under the switch kapton tape and caused a conductive path that may have switched on the cut mode inadvertently.This may be due to insufficient adhesive around the probe sleeve and handle during the bonding step.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 4 complaints, regarding 5 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).Per the instructions for use, the user is advised to not pry or pull tissue using the device.Do not bend the electrode shaft as insulation may be damaged.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the ia-2379, linvatec h/c lightwave ablator, was being used during a video arthroscopy procedure on (b)(6) 2022 when it was reported, ¿surgery was in progress and radiofrequency was working normally, and after approx.Twenty minutes began to ring, without pressing the button.The circulator in the room had to turn off the device to prevent further damage.¿ there was no report of medical intervention or hospitalization for the patient.The procedure was completed with another ia-2379 device which caused a 20-minute delay in the procedure.Further assessment questioning found that the term ¿ring¿ said in the initial report was meant to say ¿run¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: LINVATEC H/C LIGHTWAVE ABLATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 13969953
• Report Number: 1320894-2022-00071
• Device Sequence Number: 5053265
• Product Code: GEI
• UDI-Device Identifier: 10845854040355
• UDI-Public: (01)10845854040355(17)261107(30)1(10)202111081
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K083281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: IA-2379
• Device Lot Number: 202111081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic