FDA Adverse Event Malfunction Summary report: N

DEXTER

MDR report key: 23616367 · Received November 21, 2025

Report

Report Number: 3033118964-2025-00002
Event Type: Malfunction
Date Received: November 21, 2025
Date of Event: October 23, 2025
Report Date: November 21, 2025
Manufacturer: DISTALMOTION SA
Product Code: SDD
UDI-DI: 07640184840622
PMA / PMN Number: K251197
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

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.

Description of Event or Problem · 0

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2117399	DEXTER	DEXTER MONOPOLAR HOOK	SDD	DISTALMOTION SA	520	520A202502X11546	07640184840622

Patients

Seq	Age	Sex	Outcome	Treatment
1	35 YR	Female