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	10/31/2024
Type of Reportable Event	Malfunction
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
A distributor reported on behalf of a customer that the aes-90sn, arthroscopic energy 90° probe with suction, 13 cm device was used in a hip inspection procedure on (b)(6) 2024, and ¿the burning part of the tip of the edge ascopic 90° probe w.Suction came off during use, and it had to be located in the patient's joint, which caused additional time for the operation and a possible danger for the patient.".The procedure was completed with an alternate same device and a delay of ¿about 30 minutes¿.Further assessment found that "the pieces were removed.The patient did not need additional treatment because of this.Patient status is normal".There was no report of injury, medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
A distributor reported on behalf of a customer that the aes-90sn, arthroscopic energy 90° probe with suction, 13 cm device was used in a hip inspection procedure on (b)(6) 2024, and ¿the burning part of the tip of the edge ascopic 90° probe w.Suction came off during use, and it had to be located in the patient's joint, which caused additional time for the operation and a possible danger for the patient.".The procedure was completed with an alternate same device and a delay of ¿about 30 minutes¿.Further assessment found that "the pieces were removed.The patient did not need additional treatment because of this.Patient status is normal".There was no report of injury, medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned for evaluation, but photographic evidence has been provided.Root cause cannot be determined, however, based upon engineering input; a possible cause of this event could be 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.(b)(4).Per the instructions for use, the user is advised the following: 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 per regulatory requirements to help ensure patient safety.
Additional Manufacturer Narrative
Update: examinations of the returned used device, item aes-90sn, found electrode broken off at the tip.Broken piece was not returned for evaluation.Examination was performed per edge probes, standard work line #1, mp-09-1770.Root cause cannot be determined, however, based upon engineering input; a possible cause of this event could be 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.A two-year lot history review shows a total of 1 device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 78 reports, regarding 81 devices, for this device family and failure mode.During this same time frame 226,619 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 0.0004.Per the instructions for use, the user is advised the following: 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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
A distributor reported on behalf of a customer that the aes-90sn, arthroscopic energy 90° probe with suction, 13 cm device was used in a hip inspection procedure on 31oct24, and ¿the burning part of the tip of the edge ascopic 90° probe w.Suction came off during use, and it had to be located in the patient's joint, which caused additional time for the operation and a possible danger for the patient.".The procedure was completed with an alternate same device and a delay of ¿about 30 minutes¿.Further assessment found that "the pieces were removed.The patient did not need additional treatment because of this.Patient status is normal".There was no report of injury, medical/surgical intervention or extended hospitalization required for the patient.This report is being raised on the basis of 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 20735448
• Report Number: 1320894-2024-00393
• Device Sequence Number: 8648982
• Product Code: GEI
• UDI-Device Identifier: 10653405006473
• UDI-Public: (01)10653405006473(17)290805(10)202408061
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K153499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2025

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: AES-90SN
• Device Lot Number: 202408061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 12/26/2024; 02/26/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/09/2025; 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic