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 Type  malfunction  

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

The customer reported that aes-90sn, aes-90sn probe assy,suct,sin was being used in a shoulder arthroscopy procedure on an unknown date and ¿when using the 90 degree wand during a shoulder arthroscopy the round metal part of the tip broke off into the shoulder.Dr.Had this happen 3 times all with the same lot number¿.The procedure was completed with a delay of unknown duration.Further assessment determined that ¿they did recover the tip¿.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned and no photographic evidence has been provided; therefore, the reported event 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.A 2 year lot history review shows a total of 3 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 54 reports, regarding 856 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 customer reported that aes-90sn, aes-90sn probe assy,suct,sin was being used in a shoulder arthroscopy procedure on an unknown date and ¿when using the 90 degree wand during a shoulder arthroscopy the round metal part of the tip broke off into the shoulder.Dr.Had this happen 3 times all with the same lot number¿.The procedure was completed with a delay of unknown duration.Further assessment determined that ¿they did recover the tip¿.There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient or user.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: 17681706
• MDR Text Key: 322608102
• Report Number: 1320894-2023-00172
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10653405006473
• UDI-Public: (01)10653405006473(17)280610(10)202306121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

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: 202306121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic