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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2022

Event Type  malfunction  

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 Description

The sales representative reported on behalf of the customer that the d4240, ergo 2-button shaver handpiece, was being used during a right hip arthroscopy procedure on (b)(6) 2022 when it was reported, device ¿overheated during right hip arthroscopy and burr that was in use melted at the base (where burr inserts into shaver hand piece).Pt was assessed and deemed not visibly affected per surgeon, shaver and burr was swapped out immediately and surgery continued.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed with an alternate, unknown device with a 2-minute delay.Further assessment questioning regarding the bur was sent to the reporter; however, the questions were not answered by the reporter.There was no report of any fragmentation of the bur.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Unit pass evaluation with no fault found.Unit tested and met specifications.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 previous service data was found.(b)(4).Per the instructions for use, the user is advised to 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.Running the shaver blade or bur without fluid flow (dry) may cause damage to the handpiece or may cause the bur hubs to melt due to excessive heat.Do not apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear), motor seizure, and overheating.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the d4240, ergo 2-button shaver handpiece, was being used during a right hip arthroscopy procedure on (b)(6) 2022 when it was reported, device ¿overheated during right hip arthroscopy and burr that was in use melted at the base (where burr inserts into shaver hand piece).Pt was assessed and deemed not visibly affected per surgeon, shaver and burr was swapped out immediately and surgery continued.¿.There was no report of injury, medical intervention, or hospitalization for the patient or user.The procedure was completed with an alternate, unknown device with a 2-minute delay.Further assessment questioning regarding the bur was sent to the reporter; however, the questions were not answered by the reporter.There was no report of any fragmentation of the bur.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: 15469257
• MDR Text Key: 306183659
• Report Number: 1017294-2022-00095
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 10845854013144
• UDI-Public: (01)10845854013144(11)201103
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D4240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic