MAUDE Adverse Event Report: CONMED UTICA AES-90SN PROBE ASSY,SUCT,SIN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number AES-90SN

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2023

Event Type  malfunction  

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 Description

The sales representative reported on behalf of the customer that the aes-90sn, aes-90sn probe assy,suct,sin, was being used during a shoulder arthroscopy procedure on (b)(6) 2023 when it was reported, ¿today during one of our arthroscopic shoulder cases one of the ablator probes malfunctioned.The metal end of the tip came apart from the end of the probe and was in the patient.We were able to retrieve the piece and it is with the probe and its box.The little metal round covering that covers the burning end came off.She was able to retrieve it with no harm to the patient, and she completed the surgery.".The procedure was completed with a 10-minute delay.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Event Description

The sales representative reported on behalf of the customer that the aes-90sn, aes-90sn probe assy,suct,sin, was being used during a shoulder arthroscopy procedure on (b)(6) 2023 when it was reported, ¿today during one of our arthroscopic shoulder cases one of the ablator probes malfunctioned.The metal end of the tip came apart from the end of the probe and was in the patient.We were able to retrieve the piece and it is with the probe and its box.The little metal round covering that covers the burning end came off.She was able to retrieve it with no harm to the patient, and she completed the surgery.".The procedure was completed with a 10-minute delay.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Examination of the returned used device found the electrode detached from the probe tip.Detached electrode was not returned for evaluation.A likely cause of the event is due to contact with another metal object during the procedure.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.(b)(4).The user is advised the following: not use the probe for mechanical displacement of tissue, damage to the probe may occur.The ifu also advises the user to maintain the probe tip, including the return electrode, in the field of view at all times.Injuries to the patient may result from inadvertent activation or movement of an activated probe outside the field of view.Care should be taken in procedures that may cover the probe return electrode.Alternate site ablation may occur if 75% of the return electrode is masked, making the return electrode surface area smaller than that of the active electrode.Do not activate the probe while any portion of the active or return electrode 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.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: AES-90SN PROBE ASSY,SUCT,SIN
• Type of Device: 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: 18010149
• MDR Text Key: 326564525
• Report Number: 1320894-2023-00236
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10653405006473
• UDI-Public: (01)10653405006473(17)280108(10)202301091
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K153499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AES-90SN
• Device Lot Number: 202301091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic