MAUDE Adverse Event Report: CONMED 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)
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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
This complaint was created due to the receipt of medsun report no.(b)(4), received on 17dec25.A search of the complaint system has found no complaint reported for this device/lot number during this timeframe.The report was found to be written against the aes-90sn, arthroscopic energy 90° probe with suction, 13 cm.This was reported as a product problem not an adverse event.The report states that on an unknown date in (b)(6) 2025, the ¿tip of arthroscopic probe hit the cannula and popped off, when we took the probe out, we noticed the piece was missing and was able to go back in and retrieve the tip in it's entirety.Case finished without complications.¿.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
This complaint was created due to the receipt of medsun report no.(b)(4), received on 17dec2025.A search of the complaint system has found no complaint reported for this device/lot number during this timeframe.The report was found to be written against the aes-90sn, arthroscopic energy 90° probe with suction, 13 cm.This was reported as a product problem not an adverse event.The report states that on an unknown date in (b)(6) 2025, the ¿tip of arthroscopic probe hit the cannula and popped off, when we took the probe out we noticed the piece was missing and was able to go back in and retrieve the tip in it's entirety.Case finished without complications.¿.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event 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.(b)(4).Per the instructions for use, the user is advised the following: examine all accessories and connections to the generator before use.Ensure all accessories are properly and securely connected and function as intended.Improper connection may result in arcing, sparking, or malfunction of the device, any of which can result in an unintended surgical effect, injury, or equipment damage.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.

• Brand Name: CONMED
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED; 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: 23905831
• Report Number: 1320894-2025-00292
• Device Sequence Number: 21338321
• Product Code: GEI
• UDI-Device Identifier: 10653405006473
• UDI-Public: (01)10653405006473(17)300914(10)202509151
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K153499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2026

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: 202509151
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 02/11/2026; Not provided
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/12/2026; 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2025
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic