MAUDE Adverse Event Report: CONMED UTICA ARTHROSCOPIC ENERGY 50 DEGREE PROBE WITH SUCTION 18 CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number AES-50SL

Device Problem Material Fragmentation (1261)

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

Event Date 10/05/2023

Event Type  malfunction  

Event Description

The customer reported that the device, aes-50sl, arthroscopic energy 50 degree probe with suction 18 cm, was being used during an arthroscopy procedure on (b)(6) 2023 when it was reported, ¿the tip broke during surgery.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The fragmentation was retrieved per the photograph that was received from the reporter.The procedure was completed using an alternate, unknown device and there was no report of delay in the procedure.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

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 customer reported that the device, aes-50sl, arthroscopic energy 50 degree probe with suction 18 cm, was being used during an arthroscopy procedure on (b)(6) 2023 when it was reported, ¿the tip broke during surgery.¿.There was no report of injury, medical intervention, or hospitalization for the patient.The fragmentation was retrieved per the photograph that was received from the reporter.The procedure was completed using an alternate, unknown device and there was no report of delay in the procedure.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Examination of the returned used device, item aes-50sl confirm the reported problem, and found electrode tip detached from the device shaft.The detached electrode tip was not returned.No damage to the shaft was found.Examination was performed per edge probes, standard work line #1, mp-09-1770.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be utilizing the probe to pry and manipulate tissue exposing the distal tip to undue force and stress, or if the user utilizes the probe well over its intended life.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 two (2) devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 16 complaints, regarding 16 devices, for this device family and failure mode.During this same time frame 209,047 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 0.00007.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.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: ARTHROSCOPIC ENERGY 50 DEGREE PROBE WITH SUCTION 18 CM
• 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: 18054368
• MDR Text Key: 327134197
• Report Number: 1320894-2023-00239
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20653405004971
• UDI-Public: (01)20653405004971(17)240114(10)202207181
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K153499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2024
• Device Catalogue Number: AES-50SL
• Device Lot Number: 202207181
• 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: 07/18/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic