MAUDE Adverse Event Report: CONMED LARGO SURGAIRTOME TWO HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Catalog Number	00505800100
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the evaluation of the device has not been completed.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 or Problem Description
A sales representative reported on behalf of the customer that the device, 00505800100, surgairtome two handpiece, was being used during an unnamed procedure on (b)(6) 2023, and the ¿overheated surgairtome resulted in a burn to the patients inner lip¿.The customer confirmed ¿it was a first degree burn.They treated it with ointment, no surgical intervention.The patient is currently ¿ok¿.The surgery was completed successfully.¿.The 00137501200 will be listed as a concomitant device and there is no allegation against it.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
A sales representative reported on behalf of the customer that the device, 00505800100, surgairtome two handpiece, was being used during an unnamed procedure on (b)(6) 2023, and the ¿overheated surgairtome resulted in a burn to the patients inner lip¿.The customer confirmed ¿it was a first degree burn.They treated it with ointment, no surgical intervention.The patient is currently ¿ok¿.The surgery was completed successfully.¿.The 00137501200 will be listed as a concomitant device and there is no allegation against it.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The evaluation found that the lever is worn.There was no evidence of excessive heat generation.The handpiece was last repaired in november 2020; therefore, the device pm is overdue.The recommended schedule is 12 months.The handpiece passed all other testing criteria.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.(b)(4).Per the instructions for use, the user is advised: to continually check all handpieces and attachments for overheating.If overheating is sensed, immediately discontinue use and return equipment for service.Overheating of the bur or bit may cause damage to the bur or bit and may cause burns or thermal necrosis.Failure to follow the maintenance schedule above could result in reduced instrument performance or overheating of the handpiece or attachment.Overheating can lead to possible burn injury to the patient or medical personnel.Rotation of handpiece usage per day will assist with proper performance.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: SURGAIRTOME TWO HANDPIECE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
• 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: 18344277
• Report Number: 1017294-2023-00123
• Device Sequence Number: 14871301
• Product Code: HSZ
• UDI-Device Identifier: 20845854018924
• UDI-Public: 20845854018924
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K781979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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: 00505800100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2010
• 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: 00137501200, BUR GUARD, MEDIUM; 00137501200, BUR GUARD, MEDIUM
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic