Single Use Preloaded Sphincterotome V(Distal Wireguided) KD-VC611Q-07203S (REF N5778630)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170399428), received between Jun 9, 2021 and Apr 5, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED, DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AFTER REMOVAL OF THE BILIARY PROSTHESIS, THE PHYSICIAN USED THE SPHINCTEROTOME TO ENTER THE PAPILLA OF THE BILE DUCTS NOT VISIBLE THROUGH A DIVERTICULUM IN ORDER TO VISUALIZE STENOSIS OR STONES. WHEN THE SUBJECT DEVICE WAS REMOVED FROM THE SCOPE, THE NURSE NOTICED THAT THE PIECE OF METAL USED TO BANDAGE IT WAS CUT IN HALF AND ONE OF THE TWO PARTS WERE MISSING. THE PIECE WAS SEARCHED IN THE WORKING CHANNEL AND INSIDE THE PATIENT WITH THE ENDOSCOPE CAMERA, BUT IT WAS NOT FOUND. THE PIECE MAY HAVE REMAINED IN THE DUODENUM BUT REPORTEDLY, IT WAS SO SMALL AND THIN, THERE WAS LITTLE RISK FOR THE PATIENT. IT WAS ALSO NOT VISIBLE BY RADIOGRAPH. THE PROCEDURE WAS PROLONGED BY 30 MINUTES. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 19051716 ↗
• MalfunctionJun 9, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE CUSTOMER THAT DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) TO REMOVE STONES IN THE BILE DUCT USING THE SUBJECT DEVICE, THE FOLLOWING EVENT OCCURRED. THE PAPILLA WAS PUNCTURED WITH THE DEVICE AND THE WIRE WAS PLACED. THEN THE DEVICE WAS REMOVED. THE WIRE WAS LEFT IN PLACE. AN EXTRACTION BALLOON WAS PUSHED INTO THE BILE DUCT OVER THE WIRE. THE BLACK PARTS WERE SEEN AT THE PAPILLA AND IT WAS ASSUMED THAT THE WIRE WAS TORN OFF. THESE PARTS WERE RECOVERED WITH THE BIOPSY FORCEPS. THE PATIENT WAS NOT INJURED OR HARMED. THERE WAS NO PROLONGATION OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971462 ↗