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 07/12/2023

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.H3 other text : device not yet received.

Event Description

The distributor reported on behalf of the customer that the aes-90sn, aes-90sn probe assy,suct,sin was being used during an arthroscopy procedure on (b)(6) 2023 and ¿the arthroscopic energy probe of 90 ° presented failures (the head came off) proceeded to inform the seller mr., this input was collected, was packaged along with the rest of inputs sent by the company, to finish the surgery proceeded to open another energy probe, this time of 50 °.¿.The procedure was completed.A good faith effort was completed to obtain further information; however, to date no reply has been received.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device was returned in opened original packaging; the lot number was verified.Visual inspection of the returned device found the electrode detached from the wand; the detached electrode was not returned with the device.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 10 reports, regarding 10 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: do 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.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.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of the customer that the aes-90sn, aes-90sn probe assy,suct,sin was being used during an arthroscopy procedure on (b)(6) 2023 and ¿the arthroscopic energy probe of 90 ° presented failures (the head came off) proceeded to inform the seller mr., this input was collected, was packaged along with the rest of inputs sent by the company, to finish the surgery proceeded to open another energy probe, this time of 50 °.¿.The procedure was completed.A good faith effort was completed to obtain further information; however, to date no reply has been received.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• 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: 17681670
• MDR Text Key: 322616412
• Report Number: 1320894-2023-00170
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20653405006470
• UDI-Public: (01)20653405006470(17)280221(10)202302221
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K153499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• 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: 202302221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic