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

Catalog Number	D4240
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported that, after receiving a report that the d4240, ergo 2-button shaver handpiece device had stopped working during a procedure on (b)(6)2024, he tested this device on (b)(6) 2024 and found the ¿handle got hot quickly with use¿ and stayed hot even after he unplugged it.There was no patient involvement as this occurred outside of surgery.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
Additional Manufacturer Narrative
An evaluation of the returned device could not confirm the reported problem.Additional problems were found, the motor seized and failed hi pot test.The unit was repaired, evaluation completed and final tested.The unit met all specifications.The preventive maintenance was overdue.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.A device history record (dhr) review found a non-conformance; however, it was not related to the manufacture of the product.The service history was reviewed, and no prior data was found.A two-year review of complaint history revealed there has been a total of six reports, regarding six 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 the following: continually check handpiece for overheating.If overheating is sensed, immediately discontinue use and return equipment for service.Overheating of the blade or bur may cause damage to the blade or bur and may cause burns or thermal necrosis.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported that, after receiving a report that the d4240, ergo 2-button shaver handpiece device had stopped working during a procedure on (b)(6) 2024, he tested this device on (b)(6) 2024 and found the ¿handle got hot quickly with use¿ and stayed hot even after he unplugged it.There was no patient involvement as this occurred outside of surgery.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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18695580
• Report Number: 1017294-2024-00020
• Device Sequence Number: 8466883
• Product Code: GEY
• UDI-Device Identifier: 10845854013144
• UDI-Public: (01)10845854013144(11)220330
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K050519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: 01/16/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• 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: D4000 ARTHROSCOPY RESECTION SYSTEM; D4000 ARTHROSCOPY RESECTION SYSTEM
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic