MAUDE Adverse Event Report: CONMED LARGO ERGO 2-BUTTON SHAVER HANDPIECE; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number	D4240
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
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 d4240, ergo 2-button shaver handpiece, was being used during a arthroscopic knee procedure on (b)(6) 2022 when it was reported, ¿during knee arthro surgery, electric shock had happened therefore a customer asked investigation to conmed (b)(4) service team.(b)(4) service team found that it didn't pass our electric test due to moisture inside of the cable's component.A surgery was successful by using another shaver that they had, and the patient is fine as well.¿ there was no report of injury, medical intervention or hospitalization for the patient.The procedure was completed using another d4240 device which caused a 20-minute delay.Further assessment questioning found that both the user and patient felt the ¿shock¿ from the device.The device was used with a 9274a blade, unknown mfg.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported event of ¿electric shock occurred due to moisture inside the cable¿s component¿ is confirmed.Additionally, evaluation found the device failed hipot test.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.A non-conformance report (ncr) was found during the review; however, it is not related to the manufacture of the device.The product released for distribution was found to have met all specifications prior to shipment.The service history was reviewed, and no previous service data was found.A two-year review of complaint history revealed there has been a total of one complaint, regarding one device, for this device family and failure mode.During this same time frame 2,327 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 perform the required preoperative functional tests for the equipment and accessories prior to each use.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 d4240, ergo 2-button shaver handpiece, was being used during a arthroscopic knee procedure on 13apr22 when it was reported, ¿during knee arthro surgery, electric shock had happened therefore a customer asked investigation to conmed korea service team.Korea service team found that it didn't pass our electric test due to moisture inside of the cable's component.A surgery was successful by using another shaver that they had, and the patient is fine as well.¿ there was no report of injury, medical intervention or hospitalization for the patient.The procedure was completed using another d4240 device which caused a 20-minute delay.Further assessment questioning found that both the user and patient felt the ¿shock¿ from the device.The device was used with a 9274a blade, unknown mfg.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: ERGO 2-BUTTON SHAVER HANDPIECE
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 14393825
• Report Number: 1017294-2022-00057
• Device Sequence Number: 11264715
• Product Code: GEY
• UDI-Device Identifier: 10845854013144
• UDI-Public: (01)10845854013144(11)220118
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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: D4240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 9274A BLADE, UNKNOWN MFG
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic