Single Use Sphincterotome VRecalls & reported problems across all models

We found 4 models of Single Use Sphincterotome V by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Aug 7, 2023 and Jul 30, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Single Use Sphincterotome V recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 7, 2026Open, Classified

   Devices which did not undergo thermoforming could deform and lose performance.

   Z-1284-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Jan 7, 2026Open, Classified

   Devices which did not undergo thermoforming could deform and lose performance.

   Z-1283-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported Single Use Sphincterotome V problems

Single Use Sphincterotome V models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Single Use Sphincterotome V KD-VC433Q-0720

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall1 report
• Single Use Sphincterotome V KD-VC433Q-0730

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall0 reports
• Single Use Sphincterotome V KD-VC433Q-0720

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 report
• Single Use Sphincterotome V KD-VC433Q-0730

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 report

Recent Single Use Sphincterotome V adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663428 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED, THE SINGLE USE PRELOADED SPHINCTEROTOME THE KNIFE WIRE BROKE IMMEDIATELY AFTER APPLYING HIGH FREQUENCY TO THE SUBJECT DEVICE, IT DID NOT FELL OUT OF THE BODY. THE ISSUE OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AND THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710998 ↗
• MalfunctionAug 7, 2023Break; Break

  THE CUSTOMER REPORTED THAT HIS OLYMPUS SINGLE-USE SPHINCTEROTOME V BROKE DURING AN EST PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PHYSICIAN APPLIED ELECTRICITY APPROXIMATELY 3 TIMES, BUT THE CHARGE STOPPED COMING THROUGH. REPORTEDLY, THAT¿S WHEN IT WAS DISCOVERED THAT THE KNIFE WAS BROKEN. THE CUSTOMER CONFIRMED THAT THIS EVENT HAD NO HEALTH IMPACT ON THE PATIENT AND THAT THE PAPILLARY INCISION HAD ALREADY BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470161 ↗

Other Olympus Medical Systems Corp. products

• EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
• EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
• EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
• EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
• EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
• EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
• EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
• HD CAMERA HEAD2 models · 5,217 reports