MAUDE Adverse Event Report: CONMED LARGO SOFT TISSUE ELECTRODE BASIC KIT; HOOK DESIGN; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9731BA
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer that the 9731ba, soft tissue electrode basic kit; hook design was being used during a lateral release in the knee on (b)(6) 2022 when it was reported that ¿there was an incident with one of our hook probes (9731ba) that was involved in harming a patient leaving a third degree burn during an operation.It is my understanding that this product was plugged in improperly causing the malfunction.We were first notified during the case that the probe was not working.We advised that the probe along with a grounding pad needed to be plugged into the edge aes device (edge advanced energy generator).The surgical team then unplugged the probe from the bovie machine being used and into the edge.At this point it was unclear if they also switch the grounding pad over to the edge system as well.The end result caused a burn to the patient.¿ the procedure was completed and was said to have lasted under 1 hour.There was no reported delay to the surgery.Further assessment found the 90-degree hook probe in the 9731ba was in contact with the patient at the site of the burn.It is unclear how long the device had been in use when the burn occurred but possibly 20 minutes.The reporter is unsure the grounding pad that was used, if the skin was prepared prior to pad application, if prep was performed, where the pad was placed, in what position the pad was placed on the patient or if the patient was on a warming blanket when the incident occurred.The third-degree burn was diagnosed; however, the treatment was unknown, and the location of the burn was lateral to the knee.There was no medical/surgical intervention or extended hospitalization required for the patient.The patient¿s status is said to be "safe but burnt".The edge advanced energy generator will be listed as a concomitant device.This report is being raised on the basis of injury due to a third degree burn found lateral to the knee.
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.Device not yet received.
Additional Manufacturer Narrative
The device is not being returned and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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 (b)(4), regarding (b)(4), 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 that improper application or use of the dispersive electrode (pad) may result in a patient burn or poor performance of the ablator.If higher than normal power settings are required, check for obvious defects and proper adhesion.Do not reuse or relocate the dispersive electrode (pad) after initial application.If dispersive electrode (pad) relocation becomes necessary during the procedure, always use a new dispersive electrode (pad).Electrode gel is unnecessary and should not be applied.Risk of patient injury may be minimized by selecting a dispersive electrode (pad) site that is remote from the heat source.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the 9731ba, soft tissue electrode basic kit; hook design was being used during a lateral release in the knee on (b)(6) 2022 when it was reported that ¿there was an incident with one of our hook probes (9731ba) that was involved in harming a patient leaving a third degree burn during an operation.It is my understanding that this product was plugged in improperly causing the malfunction.We were first notified during the case that the probe was not working.We advised that the probe along with a grounding pad needed to be plugged into the edge aes device (edge advanced energy generator).The surgical team then unplugged the probe from the bovie machine being used and into the edge.At this point it was unclear if they also switch the grounding pad over to the edge system as well.The end result caused a burn to the patient.¿ the procedure was completed and was said to have lasted under 1 hour.There was no reported delay to the surgery.Further assessment found the 90-degree hook probe in the 9731ba was in contact with the patient at the site of the burn.It is unclear how long the device had been in use when the burn occurred but possibly 20 minutes.The reporter is unsure the grounding pad that was used, if the skin was prepared prior to pad application, if prep was performed, where the pad was placed, in what position the pad was placed on the patient or if the patient was on a warming blanket when the incident occurred.The third-degree burn was diagnosed; however, the treatment was unknown, and the location of the burn was lateral to the knee.There was no medical/surgical intervention or extended hospitalization required for the patient.The patient¿s status is said to be "safe but burnt".The edge advanced energy generator will be listed as a concomitant device.This report is being raised on the basis of injury due to a third degree burn found lateral to the knee.

• Brand Name: SOFT TISSUE ELECTRODE BASIC KIT; HOOK DESIGN
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: courtney pomichter ; 525 french rd; utica, NY 13502 ; 3156243170
• MDR Report Key: 15128131
• Report Number: 1017294-2022-00085
• Device Sequence Number: 17547674
• Product Code: HAW
• UDI-Device Identifier: 10845854026045
• UDI-Public: (01)10845854026045(17)260818(10)1205286
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K823424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2026
• Device Catalogue Number: 9731BA
• Device Lot Number: 1205286
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AES-1, ADVANCED ENERGY GENERATOR.; AES-1, ADVANCED ENERGY GENERATOR.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic