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	Foreign Body In Patient (2687)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
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 aes-90sn, arthroscopic energy 90° probe with suction, 13 cm was being used on (b)(6) 2024 during a rotator cuff repair and ¿we had a wand break off into a shoulder.Unable to find piece in shoulder¿.After further assessment it was found that "we had to bring in a c arm for x-ray and was never able to locate the metal piece.".The wand was being used to ablate tissue at the time of the event.The patient's condition was reported as "good".It is unknown if a 2nd surgery will be scheduled to remove the fragment.There was no prolonged hospitalization for the patient.There was a 45 minute delay to the procedure.This report is being raised due to the reported injury of device fragmentation left in the patient.
Additional Manufacturer Narrative
Reported event of the device breaking off and being retained in the patient is confirmed.The device will not be returned for evaluation, but photographic evidence has been provided.The root cause cannot be determined, however, based upon evaluation and engineering input, the likely cause of this event is excessive lateral loading force.A two-year lot history review shows a total of 2 devices for this lot number and failure mode.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 review of complaint history revealed there has been a total of 57 reports, 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 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 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 aes-90sn, arthroscopic energy 90° probe with suction, 13 cm was being used on (b)(6) 2024 during a rotator cuff repair and ¿we had a wand break off into a shoulder.Unable to find piece in shoulder¿.After further assessment it was found that "we had to bring in a c arm for x-ray and was never able to locate the metal piece.".The wand was being used to ablate tissue at the time of the event.The patient's condition was reported as "good".It is unknown if a 2nd surgery will be scheduled to remove the fragment.There was no prolonged hospitalization for the patient.There was a 45 minute delay to the procedure.This report is being raised due to the reported injury of device fragmentation left in the patient.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 20515805
• Report Number: 1320894-2024-00366
• Device Sequence Number: 8532294
• Product Code: GEI
• UDI-Device Identifier: 10653405006473
• UDI-Public: (01)10653405006473(17)290728(10)202407291
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: 202407291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic