MAUDE Adverse Event Report: CONMED UTICA CONMED; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	AES-90SL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, aes-90sl, arthroscopic energy 90° probe with suction, xl, 18 cm, quantity (b)(4) of lot: 202312011, was being used during a hip arthroscopy procedure on (b)(6) 2024 when it was reported, ¿disc dislodged from prob and into patients joint space.Both were removed.".There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with an alternate same-like device causing 10-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction 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.A two-year lot history review shows a total of (b)(4) devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(4) 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 it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of the equipment and its associated accessories.Use care when inserting into and withdrawing the probe from a cannula or tissue portal to avoid the possibility of damage to the devices and/or injury to the patient.Do not insert, withdraw or touch the active tip of the probe when power is being applied.This may result in an unintended surgical effect, injury, or device damage.Use care to avoid accidental activation of either cut or coagulation modes when not in contact with target tissue to avoid possible patient injury.Do not use the probe for mechanical displacement of tissue, damage to the probe may occur.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, aes-90sl, arthroscopic energy 90° probe with suction, xl, 18 cm, quantity (b)(4) of lot 202312011, was being used during a hip arthroscopy procedure on (b)(6) 2024 when it was reported, ¿disc dislodged from prob and into patients joint space.Both were removed.".There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with an alternate same-like device causing 10-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: CONMED
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 20382217
• Report Number: 1320894-2024-00268
• Device Sequence Number: 7944701
• Product Code: GEI
• UDI-Device Identifier: 10653405004677
• UDI-Public: (01)10653405004677(17)250529(10)202312011
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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 Expiration Date: 05/29/2025
• Device Catalogue Number: AES-90SL
• Device Lot Number: 202312011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic