MAUDE Adverse Event Report: CONMED UTICA AES-90SN PROBE ASSY,SUCT,SIN; 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	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer, that the aes-90sn, aes-90sn probe assy,suct,sin was being used on (b)(6) 2024 during an arthroscopic rotator cuff repair procedure when it was reported ¿tungsten tip lost off of aes-90sn wand.It was not clear how this happened or where the metal tip went.X-ray was taken to make sure the metal tip did not come off in the patient's shoulder.No traces of metal were seen on the patient's x-ray.The faulty aes-90sn probe was discarded and a new one was opened.The case continued with no other disruptions.Further assessment questioning found that ¿it is unknown if the tip fell into the surgical site.However, no traces of metal were seen on the patient's x-ray.The item was used during surgery and disposed of.¿.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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.
Additional Manufacturer Narrative
Reported event ¿tip lost off of aes-90sn wand¿ was confirmed.The device will not be returned for evaluation, but photographic evidence has been provided.Root cause cannot be determined, however, based upon photos; a possible cause of this event could be tip dislodgement could occur as a result of user utilizing the probe to pry and manipulate tissue exposing the distal tip to undue force and stress, or if the user utilizes the probe well over its intended life.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 one (1) device 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 to not use the probe for mechanical displacement of tissue, damage to the probe may occur.Do not activate the probe while any portion of the active or return electrode is in contact with another metal object, including the scope; localized heating of the electrode and the adjacent metal object may result in product damage and/or injury.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, aes-90sn probe assy,suct,sin was being used on (b)(6) 2024 during an arthroscopic rotator cuff repair procedure when it was reported ¿tungsten tip lost off of aes-90sn wand.It was not clear how this happened or where the metal tip went.X-ray was taken to make sure the metal tip did not come off in the patient's shoulder.No traces of metal were seen on the patient's x-ray.The faulty aes-90sn probe was discarded and a new one was opened.The case continued with no other disruptions.Further assessment questioning found that ¿it is unknown if the tip fell into the surgical site.However, no traces of metal were seen on the patient's x-ray.The item was used during surgery and disposed of.¿.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: AES-90SN PROBE ASSY,SUCT,SIN
• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 19477434
• Report Number: 1320894-2024-00148
• Device Sequence Number: 20589352
• Product Code: GEI
• UDI-Device Identifier: 10653405006473
• UDI-Public: (01)10653405006473(17)271113(10)202211141
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/19/2024

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: AES-90SN
• Device Lot Number: 202211141
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic