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	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the aes-50's, aes 50 deg probe with suction, was being used during a revision acl procedure on (b)(6) 2023 when it was reported, ¿ using an edge wand in the knee and the tip came off after about 30 secs of use.¿.It was confirmed with the reporter, who was in the case when the incident happened, that all parts of the device were retrieved.Surgeon was satisfied no part of the device was left in the joint.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with a 2-minute delay using an alternate device.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.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-50s, aes 50 deg probe with suction, was being used during a revision acl procedure on (b)(6) 2023 when it was reported, ¿ using an edge wand in the knee and the tip came off after about 30 secs of use.¿.It was confirmed with the reporter, who was in the case when the incident happened, that all parts of the device were retrieved.Surgeon was satisfied no part of the device was left in the joint.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with a 2-minute delay using an alternate device.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examination of the returned used device confirm the reported problem.The distal tip was detached from the shaft.The device tip broke loose from the welded connector.Broken tip 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.A two-year lot history review shows a total of 2 complaints for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 54 complaints, regarding 54 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: 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.If any visual damage or defects are noticed during use, stop using the device immediately and replace the device.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 for trends through the complaint system to assure patient safety.

• 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: 16760403
• Report Number: 1320894-2023-00070
• Device Sequence Number: 19598499
• Product Code: GEI
• UDI-Device Identifier: 30653405081917
• UDI-Public: (01)30653405081917(17)260919(10)202109201
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 06/06/2023
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic