MAUDE Adverse Event Report: CONMED UTICA ARTHROSCOPIC ENERGY 90 DEGREE PROBE WITH SUCTION 18 CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	AES-90SL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the aes-90sl, arthroscopic energy 90 degree probe with suction 18 cm, was being used during an artroscopic femoral-acetabolar impiegment procedure on (b)(6) 2023 when it was reported, ¿the piece in question was used for the procedure between the power level 1 and 3 of the edge, the outflow was connected in suction, after about 3 minutes of use the cutting disk split at the crack of aspiration breaking into additional 1 piece, this was found out in the filter of aspiration poket under the operation site.".There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment found that all fragmentation was removed from the patient.The procedure was completed with an alternate device causing a 2-minute delay.This report is being raised due to the reported 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.
Event or Problem Description
The sales representative reported on behalf of the customer that the aes-90sl, arthroscopic energy 90 degree probe with suction 18 cm, was being used during an artroscopic femoral-acetabolar impiegment procedure on (b)(6) 2023 when it was reported, ¿the piece in question was used for the procedure between the power level 1 and 3 of the edge, the outflow was connected in suction, after about 3 minutes of use the cutting disk split at the crack of aspiration breaking into additional 1 piece, this was found out in the filter of aspiration poket under the operation site." there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment found that all fragmentation was removed from the patient.The procedure was completed with an alternate device causing a 2-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction 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.A two-year lot history review shows a total of two (2) devices for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised the following: not to 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.

• Brand Name: ARTHROSCOPIC ENERGY 90 DEGREE PROBE WITH SUCTION 18 CM
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 18463208
• Report Number: 1320894-2024-00005
• Device Sequence Number: 19624785
• Product Code: GEI
• UDI-Device Identifier: 10653405004677
• UDI-Public: (01)10653405004677(17)250109(10)202307141
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K153499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

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 Expiration Date: 01/09/2025
• Device Catalogue Number: AES-90SL
• Device Lot Number: 202307141
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic