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 Date 10/04/2023

Event Type  Injury  

Event Description

Conmed japan reported on behalf of their customer that the device, aes-90sn probe assy,suct,sin was being used on (b)(6) 2023 during an arthroscopic rotator cuff repair procedure and ¿the electrode of the probe was broken when it was used during surgery with ablation set to 5 and coagulation set to 2 with the temperature center turned off.The doctor looked for the 1mm x 2mm fragment as soon as it was visible, but in the end, he was unable to find it, and due to scheduling reasons, he decided to leave it behind and finish the surgery.¿.The procedure was completed.Further assessment found that the fragment was left in the patient and a 2nd surgery is being considered to remove the fragment.This report is being raised due to the reported injury of fragmentation, although not found in the patient, they cannot produce the piece and its location is unknown.

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.

Manufacturer Narrative

Correction: d4 lot # was updated.Manufacturer narrative: examination of the returned used device found the electrode broken off and detached from the probe tip.Broken electrode was not returned per evaluation.Additionally, the incorrect lot number was entered; the lot number returned for evaluation is 202212121.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.A two-year review of complaint history revealed there has been a total of 52 reports, regarding (b)(4) 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: to 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.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

Conmed japan reported on behalf of their customer that the device, aes-90sn probe assy,suct,sin was being used on (b)(6) 2023 during an arthroscopic rotator cuff repair procedure and ¿the electrode of the probe was broken when it was used during surgery with ablation set to 5 and coagulation set to 2 with the temperature center turned off.The doctor looked for the 1mm x 2mm fragment as soon as it was visible, but in the end, he was unable to find it, and due to scheduling reasons, he decided to leave it behind and finish the surgery.¿.The procedure was completed.Further assessment found that the fragment was left in the patient and a 2nd surgery is being considered to remove the fragment.This report is being raised due to the reported injury of fragmentation, although not found in the patient, they cannot produce the piece and its location is unknown.

• 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: 17959329
• MDR Text Key: 325970628
• Report Number: 1320894-2023-00217
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10653405006473
• UDI-Public: (01)10653405006473(17)271211(10)202212121
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• 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: 202212121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic