MAUDE Adverse Event Report: DISTALMOTION SA DEXTER; DEXTER MONOPOLAR HOOK

Model Number	520
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During tissue coagulation in a refluxstop¿ device implantation procedure, it was reported that after approximately 40 minutes of using the monopolar hook, a spark trail indicated a defect in the tip sleeve.There was no harm to the patient.The instrument was immediately replaced, and the procedure was completed successfully and without incident.There were no reports of patient injury.
Additional Manufacturer Narrative
The monopolar hook instrument was returned for analysis.Inspection confirmed insulation damage in the tip sleeve region; two hole were observed.Review of production records revealed no manufacturing anomalies, and no evidence of material or assembly defect was found.The first hole was likely caused by contact with the distal fork under high angulation or proximity to other devices during use.This damage can compromise insulation, leading to short circuit and thermal damage when energized.The damage is consistent with mechanical stress during use; however, a definitive root cause could not be determined.The second hole was likely damaged by external interaction.The damaged insulation in contact with tissue eventually leads to short circuit when the tip of the monopolar instrument is energized.

• Brand Name: DEXTER
• Common Device Name: DEXTER MONOPOLAR HOOK
• Manufacturer (Section D): DISTALMOTION SA; route de la corniche 3b; epalinges, vaud 1066 ; SZ 1066
• Manufacturer Contact: ana pedro ; route de la corniche 3b; epalinges, vaud 1066 ; SZ 1066
• MDR Report Key: 23616367
• Report Number: 3033118964-2025-00002
• Device Sequence Number: 9032134
• Product Code: SDD
• UDI-Device Identifier: 07640184840622
• UDI-Public: (01)07640184840622(10)520A202502X11546(17)260710
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K251197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2026
• Device Model Number: 520
• Device Catalogue Number: 520
• Device Lot Number: 520A202502X11546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 55 KG