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

Model Number	520
Medical Device Problem Code	Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a cholecystectomy, a small hole was observed in the insulation of the tip sleeve of the monopolar hook instrument.While applying energy to dissect the gallbladder, sparking was noted from the hole, which resulted in one small, linear, cauterization mark to the liver capsule.The same instrument was being used for approximately 19 minutes without issues and was extracted and re-inserted just before the event.No friction was reported when passing the monopolar hook through the trocar.Since this final surgical task required less than 5 minutes, the surgeon decided to complete the procedure without replacing the instrument.This resulted in a few similar, small, cauterization marks on the liver capsule, created under full visual control and with deliberate, controlled instrument movements.Patient harm was limited to minor linear cauterization of the liver capsule, visible on video.No laceration or haemorrhage were seen; no hepatic structures were injured.No additional interventions were performed or planned.Energy source used was ethicon megadyne, set at 30.
Additional Manufacturer Narrative
During the procedure, the surgeon identified a small hole in the instrument tip insulation and he elected to continue the surgery.A single, superficial, linear cauterization mark was noted in the liver capsule.The mark did not penetrate the capsule, involved no bleeding and had caused no injury to vascular or biliary structures.No clinical treatment or follow-up action was required, and no post-operative symptoms or complications were reported.It is noted that, during such procedures, similar superficial marks may occur during standard monopolar use hook and generally require no intervention if no extensive and in the absence of bleeding or hematoma.The monopolar hook instrument was returned for analysis.Inspection confirmed insulation damage in the tip sleeve region; one hole was observed.Review of production records revealed no manufacturing anomalies, and no evidence of material or assembly defect was found.The 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.

• 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: 23666057
• Report Number: 3033118964-2025-00003
• Device Sequence Number: 13007535
• Product Code: SDD
• UDI-Device Identifier: 07640184840622
• UDI-Public: (01)07640184840622(10)520A202502X11546(17)260710
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 11/27/2025

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: 11/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 65 KG