Single Use Preloaded Sphincterotome V(Distal Wireguided) KD-VC631Q-07203S (REF N5779430)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170399503), received between Apr 15, 2024 and Apr 8, 2026 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Difficult to Insert

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823649 ↗
• InjuryDec 19, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE TIP BROKE AND FELL INTO THE PATIENT. THE CUSTOMER DID NOT RETRIEVE THE TIP.

  Patient problems: Foreign Body In Patient

  MAUDE report 23857424 ↗
• InjuryNov 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN USING THE SINGLE USE PRELOADED SPHINCTEROTOME DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN NOTICED A MARK OR DOT ON THE X-RAY IMAGE. THE DEVICE WAS TAKEN OUT TO BE INSPECTED, NO DAMAGE WAS SEEN, AND THE DEVICE WAS INSERTED BACK INTO THE SCOPE. WHEN THE WIRE WAS INSERTED BACK INTO THE BILIARY DUCT UNDER X-RAY, THE MARK OR DOT WAS GONE. A SMALL PIECE OF METAL WAS OBSERVED NEXT TO THE DUCT. THE PHYSICIAN NOTED THAT THE PIECE OF METAL CAME FROM THE WIRE, AND THAT THERE WAS A PIECE MISSING AT THE JUNCTION OF THE SOFT PART OF THE WIRE AND WIRE CORE ITSELF, WHICH COULD BE THIS PIECE OF METAL. THE PHYSICIAN DETERMINED TO LEAVE THE METAL PIECE IN PLACE SINCE IT WILL BE VOIDED NATURALLY. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 23612354 ↗
• InjuryNov 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN USING THE SINGLE USE PRELOADED SPHINCTEROTOME DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN NOTICED A MARK OR DOT ON THE X-RAY IMAGE. THE DEVICE WAS TAKEN OUT TO BE INSPECTED, NO DAMAGE WAS SEEN, AND THE DEVICE WAS INSERTED BACK INTO THE SCOPE. WHEN THE WIRE WAS INSERTED BACK INTO THE BILIARY DUCT UNDER X-RAY, THE MARK OR DOT WAS GONE. A SMALL PIECE OF METAL WAS OBSERVED NEXT TO THE DUCT. THE PHYSICIAN NOTED THAT THE PIECE OF METAL CAME FROM THE WIRE, AND THAT THERE WAS A PIECE MISSING AT THE JUNCTION OF THE SOFT PART OF THE WIRE AND WIRE CORE ITSELF, WHICH COULD BE THIS PIECE OF METAL. THE PHYSICIAN DETERMINED TO LEAVE THE METAL PIECE IN PLACE SINCE IT WILL BE VOIDED NATURALLY. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 23612332 ↗
• MalfunctionNov 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED) WAS STRIPPED AT THE TIP. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE AND WAS COMPLETED USING AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453713 ↗
• InjuryOct 21, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE SINGLE USE PRELOADED SPHINCTEROTOME WIRE BROKE AND FELL INTO THE PATIENT¿S PANCREATIC DUCT. THE SURGEON ATTEMPTED TO RETRIEVE THE BROKEN WIRE WITH GRASPING FORCEPS BUT WAS UNSUCCESSFUL. THE PATIENT RETURNED FOR AN ADDITIONAL PROCEDURE TO TRY TO REMOVE THE PIECE OF BROKEN WIRE, HOWEVER THAT WAS AGAIN UNSUCCESSFUL. A FOLLOW-UP IS SCHEDULED TO DISCUSS POSSIBLE SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23354548 ↗
• InjuryOct 21, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THIS SUPPLEMENTAL IS BEING SUBMITTED TO CORRECT CODING. UPDATES TO B2 AND F10.

  Patient problems: Foreign Body In Patient

  MAUDE report 23354542 ↗
• MalfunctionJun 24, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THE SINGLE USE PRELOADED SPHINCTEROTOME V IRON WIRE OF THE KNIFE IS BROKEN. THE ISSUE OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 22322005 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT THE CUTTING WIRE BROKE WHEN ENERGY WAS APPLIED TO THE DEVICE. TWO CUTS WERE MADE AND DEVICE FAILED. THE EVENT OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21629250 ↗
• MalfunctionMay 22, 2024Device Fell; Device Fell

  IT WAS REPORTED, THE SPHINCTEROTOME V¿S WIRE FELL OFF DURING A THERAPEUTIC PROCEDURE (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY). THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373682 ↗
• MalfunctionApr 15, 2024

  CLEVER CUT 3V USED DURING ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY), AT THE TIME OF THE SPHINCTEROTOMY DURING THE BOWING, THE WIRE BROKE WHILE AT THE AMPULLA INSIDE THE PATIENT IN THE SCOPE.

  Patient problems: Insufficient Information

  MAUDE report 19104395 ↗