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

Catalog Number	AES-90SN
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The distributor reported on behalf of their customer that the device, aes-90sn, arthroscopic energy 90° probe with suction, 13 cm, was being used during a right shoulder arthroscopy procedure on (b)(6) 2024 when it was reported, ¿during a shoulder arthroscopy procedure done by (doctor at facility) on (b)(6) 2024, the tip of the edge probe broke off.He was unable to locate the tip during the arthroscopy procedure and x-ray imaging was required to locate the tip of the edge.An extra incision was necessary to extract the tip.¿.The procedure was completed with an alternate same device causing a 40-minute delay.This report is being raised due to the reported injury of extra incision required to remove component.
Event or Problem Description
The distributor reported on behalf of their customer that the device, aes-90sn, arthroscopic energy 90° probe with suction, 13 cm, was being used during a right shoulder arthroscopy procedure on (b)(6) 2024 when it was reported, ¿during a shoulder arthroscopy procedure done by (doctor at facility) on (b)(6) 2024, the tip of the edge probe broke off.He was unable to locate the tip during the arthroscopy procedure and x-ray imaging was required to locate the tip of the edge.An extra incision was necessary to extract the tip.¿.The procedure was completed with an alternate same device causing a 40-minute delay.This report is being raised due to the reported injury of extra incision required to remove component.
Additional Manufacturer Narrative
Examination of the returned used device, item aes-90sn, found device electrode broken off and detached from the probe tip.The broken electrode was not returned per evaluation.The root cause cannot be determined, however, based upon evaluation and engineering input, the likely cause of this event is excessive lateral loading force.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 57 complaints, regarding 60 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.

• 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: 20277693
• Report Number: 1320894-2024-00254
• Device Sequence Number: 15456959
• Product Code: GEI
• UDI-Device Identifier: 10653405006473
• UDI-Public: (01)10653405006473(17)290407(10)202404081
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K153499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AES-90SN
• Device Lot Number: 202404081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic