MAUDE Adverse Event Report: CONMED CORPORATION LINVATEC H/C LIGHTWAVE ABLATOR 90 DEGREE ANGLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number IA-2379

Device Problem Unintended Electrical Shock (4018)

Patient Problems Electric Shock (2554); No Information (3190)

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

Although attempts have been made to gather additional information, at the time of this reporting, no clarification has been received.Although expected, the reported device has not been 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

Conmed received notification of an issue with the linvatec h/c lightwave ablator , item # ia-2379, lot # 201708021 that occurred on (b)(6) 2019.It was reported only that when the device was activated, an electric shock was emitted.Although attempts have been made to gather additional information, at the time of this reporting, no clarification has been received.

Manufacturer Narrative

Although attempts have been made to gather additional information, at the time of this reporting, no clarification has been received and the reporter indicates no information is forthcoming.Although originally expected, the reported device has not been returned for evaluation.The investigation of the reported complaint is inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified, root cause could not be identified.The manufacturing documents from the device history record and lot history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.A two-year lot history review was conducted and found no other similar complaints for this lot number and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user not to wrap ablator, footswitch, or generator power cord around metal objects.Wrapping cables around metal objects my induce currents that could lead to shock, fire or injury to patient or surgical personnel.Examine all accessories and connections to the generator before use.Ensure all accessories are properly and securely connected and function as intended.Improper connection may result in arcing, sparking, or malfunction of the device, any of which can result in an unintended surgical effect, injury, or equipment damage.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: LINVATEC H/C LIGHTWAVE ABLATOR 90 DEGREE ANGLE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 9130437
• MDR Text Key: 176256437
• Report Number: 1320894-2019-00343
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K083281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

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: No Information
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: IA-2379
• Device Lot Number: 201708021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 11/14/2019
• Patient Sequence Number: 1