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

Catalog Number	AES-30
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This report was created due to the receipt of a mhra report number (b)(4).The report states the aes-30, arthroscopic energy 30° probe, 8.5 cm was being used on (b)(6) 2026 and the ¿patient was undergoing wrist arthroscopy, during the procedure when using radiofrequency wand inside the patient's wrist, the end section of the instrument broke off, the instrument is a single use item.The retained section of the instrument was removed easily by the surgeon.No harm to the patient.¿ there was no report of impact or injury to the patient or user.This report is being raised due to the reported 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.A root cause cannot be determined; however, based upon risk document for the device, a possible cause of this event could be the probe was used to pry and manipulated hard and soft tissue, exposing the distal tip to undue force and stress, resulting in tip dislodgment.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 (b)(4) reports, 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 the following: to 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.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: robin drum ; 1311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 24257049
• Report Number: 1320894-2026-00024
• Device Sequence Number: 18219974
• Product Code: GEI
• UDI-Device Identifier: 30653405064149
• UDI-Public: (01)30653405064149(17)300907(10)202509081
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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-30
• Device Lot Number: 202509081
• 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: 01/15/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic