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

Catalog Number D4240

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 03/08/2023

Event Type  Injury  

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.

Event Description

The customer reported that the device, d4240, ergo 2-button shaver handpiece, was being used during a rotator cuff repair procedure on (b)(6) 2023 when it was reported, ¿during a distal clavicle excision doctor experienced and overhearing of the 4.5 vortex router using d4240 ergo shaver.Doctor said the shaver handle got warm but when he went to remove the bur to put the shaver blade in it was hot to the touch and is concerned this burned patient.Am incident report has been filed by the or and the shaver handpiece is being isolated.¿.Initially there was no report of injury, medical intervention, or hospitalization for the user.Further assessment questions were asked, and we have been informed that the patient did receive a ¿burn mark¿; however, the degree of burn is not known.There has been not further report of medical intervention or hospitalization since that communication.This report is being raised on the basis of injury due to unknown degree of burn.

Manufacturer Narrative

The device has not been returned to date and no photographic evidence has been provided; therefore, the reported event 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.The service history was reviewed and no relationship to this complaint was found.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding 29 devices, for this device family and failure mode.(b)(4).Per the instructions for use, the user is advised the following: run the handpiece for less than 5 seconds at a speed less than 1500 rpm to observe any abnormal noises, vibrations or heat rise.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the device, d4240, ergo 2-button shaver handpiece, was being used during a rotator cuff repair procedure on (b)(6) 2023 when it was reported, ¿during a distal clavicle excision doctor experienced and overhearing of the 4.5 vortex router using d4240 ergo shaver.Doctor said the shaver handle got warm but when he went to remove the bur to put the shaver blade in it was hot to the touch and is concerned this burned patient.Am incident report has been filed by the or and the shaver handpiece is being isolated.¿.Initially there was no report of injury, medical intervention, or hospitalization for the user.Further assessment questions were asked, and we have been informed that the patient did receive a ¿burn mark¿; however, the degree of burn is not known.There has been not further report of medical intervention or hospitalization since that communication.This report is being raised on the basis of injury due to unknown degree of burn.

• Brand Name: ERGO 2-BUTTON SHAVER HANDPIECE
• Type of Device: 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: 16654298
• MDR Text Key: 312407343
• Report Number: 1017294-2023-00029
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 10845854013144
• UDI-Public: (01)10845854013144(11)160201(30)1
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D4240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic