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 Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

The sales representative reported on behalf of the customer that the aes-90sn, aes-90sn probe assy,suct,sin was being used on an unknown date during a rotator cuff repair and the ¿tungsten tip caught on tissue and pulled off the wand head.Quarter of the tungsten tip broke off and is possibly still in situ.¿.There was no report of impact or injury to the patient or user.The procedure was completed with an alternate device ¿replacement cart¿.There was a 30 minute delay to the procedure.This report is being raised due to the reported injury of fragmentation left in the patient.

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 Description

Update: per assessment received on 5mar24 the procedure was completed and the fragment "did not fall in as the wand was inside the patient, it could not be retrieved as it could not be located after washing away in surgical fluid.".The patient's current status was reported as "routine recovery at present".There was no prolonged hospitalization for the patient.The sales representative reported on behalf of the customer that the aes-90sn, aes-90sn probe assy,suct,sin was being used on an unknown date during a rotator cuff repair and the ¿tungsten tip caught on tissue and pulled off the wand head.Quarter of the tungsten tip broke off and is possibly still in situ.¿.There was no report of impact or injury to the patient or user.The procedure was completed with an alternate device ¿replacement cart¿.There was a 30 minute delay to the procedure.This report is being raised due to the reported injury of fragmentation left in the patient.

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.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 57 reports, regarding 860 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: 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.If partial coverage of the return electrode is required for the procedure, use a lower setting and maintain visibility of the return electrode while applying rf.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.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-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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18746810
• MDR Text Key: 335865703
• Report Number: 1320894-2024-00037
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10653405006473
• UDI-Public: (01)10653405006473(17)280611(10)202306131
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K153499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AES-90SN
• Device Lot Number: 202306131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• 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 Outcome(s): Other
• Patient Ethnicity: Non Hispanic