Single Use Preloaded Sphincterotome VRecalls & reported problems across all models
Olympus Medical Systems Corp. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 11 models of Single Use Preloaded Sphincterotome V by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2019 and Sep 21, 2026 — classified as 43 malfunctions.
The most frequently reported specific device problem is “Break” (39 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. 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
Reports received per month, all models
Most reported Single Use Preloaded Sphincterotome V problems
Device problems
- Break39
- Material Fragmentation3
- Peeled/Delaminated3
- Detachment of Device or Device Component1
- Device Fell1
- Material Split, Cut or Torn1
- Melted1
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Consequences Or Impact To Patient2
Single Use Preloaded Sphincterotome V models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Single Use Preloaded Sphincterotome V KD-V611M-07251SUnit, electrosurgical, endoscopic (with or without accessories)18 reports
- Single Use Preloaded Sphincterotome V KD-V611M-07301SUnit, electrosurgical, endoscopic (with or without accessories)7 reports
- Single Use Preloaded Sphincterotome V KD-V611M-07302SUnit, electrosurgical, endoscopic (with or without accessories)4 reports
- Single Use Preloaded Sphincterotome V KD-V631M-07202SUnit, electrosurgical, endoscopic (with or without accessories)4 reports
- Single Use Preloaded Sphincterotome V KD-V631M-07201SUnit, electrosurgical, endoscopic (with or without accessories)3 reports
- Single Use Preloaded Sphincterotome V KD-V631M-07301SUnit, electrosurgical, endoscopic (with or without accessories)2 reports
- Single Use Preloaded Sphincterotome V KD-V611M-07301SUnit, electrosurgical, endoscopic (with or without accessories)1 report
- Single Use Preloaded Sphincterotome V KD-V631M-07202SUnit, electrosurgical, endoscopic (with or without accessories)1 report
- Single Use Preloaded Sphincterotome V KD-V611M-07201SUnit, electrosurgical, endoscopic (with or without accessories)1 report
- Single Use Preloaded Sphincterotome V KD-V611M-07202SUnit, electrosurgical, endoscopic (with or without accessories)1 report
- Single Use Preloaded Sphincterotome V KD-V631M-07302SUnit, electrosurgical, endoscopic (with or without accessories)1 report
Recent Single Use Preloaded Sphincterotome V adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Break; Material Split, Cut or Torn
It was reported that the the cutting wire of the Sphincterotome reportedly split and subsequently broke during the application of electrical current and its axis to rotated to the left and creating a potential risk of perforation. The issue occurred during a therapeutic Endoscopic Retrograde Cholangiopancreatography procedure. Additional information received there was no perforation. The patient is doing very well and has already been discharged home. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50847297 ↗MalfunctionMay 5, 2026Break; Peeled/Delaminated
IT WAS REPORTED THE SINGLE USE SPHINCTEROTOME CUTTING WIRE BROKE AT THE PROXIMAL END SITE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25083019 ↗MalfunctionMar 17, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24620165 ↗MalfunctionMar 12, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24581339 ↗MalfunctionMar 11, 2026Break; Material Fragmentation
IT WAS REPORTED THE SINGLE USE PRELOADED SPHINCTEROTOME CUTTING WIRE RUPTURED. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24572067 ↗MalfunctionMar 11, 2026Break; Material Fragmentation
IT WAS REPORTED THE SINGLE USE PRELOADED SPHINCTEROTOME NEEDLE CUTTING WIRE RUPTURED DURING INCISION. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24572002 ↗MalfunctionMar 2, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24486905 ↗MalfunctionJan 30, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223729 ↗MalfunctionJan 30, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223637 ↗MalfunctionJan 30, 2026Break; Material Fragmentation
IT WAS REPORTED THE SINGLE USE PRELOADED SPHINCTEROTOME HAD A BROKEN WIRE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AND WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223573 ↗MalfunctionFeb 20, 2025Break; Break
IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED AFTER A DELAY OF THREE MINUTES WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21421542 ↗MalfunctionFeb 19, 2025Break; Break
IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21416442 ↗MalfunctionFeb 19, 2025Break; Break
IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED AFTER A DELAY OF THREE MINUTES WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21416208 ↗MalfunctionFeb 19, 2025Break; Break
IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED AFTER A DELAY OF THREE MINUTES WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21416013 ↗MalfunctionFeb 19, 2025Break; Break
IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE WIRE OF THE SINGLE USE SUBJECT DEVICE WAS ABOUT TO BREAK, AND THE INSULATION OF THE WIRE WAS OBSERVED TO BE HANGING DOWN. THIS WAS OBSERVED IN TEN (10) CASES PREVIOUSLY. EACH PROCEDURE WAS COMPLETED AFTER A DELAY OF THREE MINUTES WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21415402 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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