MAUDE Adverse Event Report: CONMED UTICA AES 50 DEG PROBE WITH SUCTION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AES-50S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of their customer that the aes-50s, aes 50 deg probe with suction, was being used during a knee arthroscopy procedure on (b)(6) 2022 when it was reported, ¿when performing ablation with normal level of intra-articular temperature 32 degree celsius we discovered that the tip of the probe is entirely separated from the probe.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported as being completed without any delay.Further assessment questioning found that the component had fallen into the surgical site and was removed with forceps.The reporter states that the current status of the patient is ¿very good¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Examinations of the returned used device, item aes-50s confirm the reported problem and found probe electrode detached from the probe tip.Detached electrode was not returned for evaluation.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 24 complaints, regarding 24 devices, for this device family and failure mode.(b)(4).Per the instructions for use, the user is advised to always maintain the active probe tip in the field of view.Injuries to the patient may result from inadvertent activation or movement of an activated probe outside the field of view.Do not activate the electrode while any portion of the electrode tip 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.Electrodes and probes of monitoring, stimulating, and imaging devices can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 50/60 hz.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the aes-50s, aes 50 deg probe with suction, was being used during a knee arthroscopy procedure on 1aug22 when it was reported, ¿when performing ablation with normal level of intra-articular temperature 32 degree celsius we discovered that the tip of the probe is entirely separated from the probe.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported as being completed without any delay.Further assessment questioning found that the component had fallen into the surgical site and was removed with forceps.The reporter states that the current status of the patient is ¿very good¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: AES 50 DEG PROBE WITH SUCTION
• 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: 15247909
• Report Number: 1320894-2022-00177
• Device Sequence Number: 14905063
• Product Code: GEI
• UDI-Device Identifier: 30653405081917
• UDI-Public: (01)30653405081917(17)260919(10)202109201
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K140578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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: 09/19/2026
• Device Model Number: AES-50S
• Device Catalogue Number: AES-50S
• Device Lot Number: 202109201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic