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

Model Number	518
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the dissection of the peritoneum for an epigastric ventral hernia using a tapp procedure, it was reported that after 36 minutes of robotic console time, monopolar energy was delivered via the tip sleeve of the monopolar scissors to tissue on already charred and coagulated anatomical planes.No critical structures such as nerves or vessels present or impacted.Visualization of the instrument by the endoscope under 10x modification did not observe any defect.Although an instrument exchange was recommended, the surgeon opted to continue with the existing device due to its adequate energy delivery at the tip and overall satisfactory performance and did not wish to prolong the procedure to exchange the instrument.Energy application during the procedure was consistently deemed safe, as the surgeon maintained clear visual control over the location, timing, and intensity of energy delivery to the intended tissue.The malfunction carried only a minor risk of injury and the procedure was completed successfully and without incident, no harm occurred that required medical or surgical intervention.
Additional Manufacturer Narrative
The monopolar scissors instrument was returned for analysis.Inspection confirmed insulation damage in the tip sleeve region; two holes were observed.Review of production records revealed no manufacturing anomalies, and no evidence of material or assembly defect was found.The holes were 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.
Event or Problem Description
During the dissection of the peritoneum for an epigastric ventral hernia using a tapp procedure, it was reported that after 36 minutes of robotic console time, monopolar energy was delivered via the tip sleeve of the monopolar scissors to tissue on already charred and coagulated anatomical planes.No critical structures such as nerves or vessels present or impacted.Visualization of the instrument by the endoscope under 10x modification did not observe any defect.Although an instrument exchange was recommended, the surgeon opted to continue with the existing device due to its adequate energy delivery at the tip and overall satisfactory performance and did not wish to prolong the procedure to exchange the instrument.Energy application during the procedure was consistently deemed safe, as the surgeon maintained clear visual control over the location, timing, and intensity of energy delivery to the intended tissue.The malfunction carried only a minor risk of injury and the procedure was completed successfully and without incident, no harm occurred that required medical or surgical intervention.

• Brand Name: DEXTER
• Common Device Name: DEXTER MONOPOLAR SCISSORS
• 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: 23368557
• Report Number: 3033118964-2025-00001
• Device Sequence Number: 21362919
• Product Code: SDD
• UDI-Device Identifier: 07640184840608
• UDI-Public: (01)07640184840608(10)518A202503X11547(17)260714
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 10/23/2025

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: 07/14/2026
• Device Model Number: 518
• Device Catalogue Number: 518
• Device Lot Number: 518A202503X11547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 80 KG