Single Use Preloaded Sphincterotome V (Distal Wireguided)Recalls & reported problems across all models
Olympus Medical Systems Corp. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 94
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 18 models of Single Use Preloaded Sphincterotome V (Distal Wireguided) by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 94 adverse event reports in the FDA's MAUDE database, received between Jan 10, 2019 and Apr 21, 2026 — classified as 8 injuries, 86 malfunctions.
The most frequently reported specific device problem is “Break” (62 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 (Distal Wireguided) problems
Device problems
- Break62
- Material Split, Cut or Torn11
- Detachment of Device or Device Component10
- Peeled/Delaminated7
- Material Protrusion/Extrusion5
- Sharp Edges5
- Material Frayed4
- Flare or Flash2
Patient problems
- No Clinical Signs, Symptoms or Conditions70
- No Consequences Or Impact To Patient10
- Foreign Body In Patient6
- Insufficient Information5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Hemorrhage/Blood Loss/Bleeding1
- Injury1
- Perforation1
Single Use Preloaded Sphincterotome V (Distal Wireguided) models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC611Q-07301SUnit, electrosurgical, endoscopic (with or without accessories)21 reports
- Single Use Preloaded Sphincterotome V(Distal Wireguided) KD-VC631Q-07203SUnit, electrosurgical, endoscopic (with or without accessories)11 reports
- Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC611Q-07201SUnit, electrosurgical, endoscopic (with or without accessories)10 reports
- Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC611Q-07301SUnit, electrosurgical, endoscopic (with or without accessories)8 reports
- Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q-07301AUnit, electrosurgical, endoscopic (with or without accessories)6 reports
- Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q-07201SUnit, electrosurgical, endoscopic (with or without accessories)6 reports
- Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q-07301SUnit, electrosurgical, endoscopic (with or without accessories)6 reports
- Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC611Q-07201SUnit, electrosurgical, endoscopic (with or without accessories)4 reports
- Single Use Preloaded Sphincterotome V(Distal Wireguided) KD-VC631Q-07203SUnit, electrosurgical, endoscopic (with or without accessories)4 reports
- Single Use Preloaded Sphincterotome V(Distal Wireguided) KD-VC611Q-07303SUnit, electrosurgical, endoscopic (with or without accessories)4 reports
- Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q-07201SUnit, electrosurgical, endoscopic (with or without accessories)3 reports
- Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q-07301SUnit, electrosurgical, endoscopic (with or without accessories)3 reports
- Single Use Preloaded Sphincterotome V(Distal Wireguided) KD-VC611Q-07203SUnit, electrosurgical, endoscopic (with or without accessories)2 reports
- Single Use Preloaded Sphincterotome V(Distal Wireguided) KD-VC611Q-07203SUnit, electrosurgical, endoscopic (with or without accessories)2 reports
- Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC611Q-07301AUnit, electrosurgical, endoscopic (with or without accessories)1 report
- Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q-07301AUnit, electrosurgical, endoscopic (with or without accessories)1 report
- Single Use Preloaded Sphincterotome V(Distal Wireguided) KD-VC631Q-07303SUnit, electrosurgical, endoscopic (with or without accessories)1 report
- Single Use Preloaded Sphincterotome V(Distal Wireguided) KD-VC631Q-07203AUnit, Electrosurgical, Endoscopic (With Or Without Accessories)1 report
Recent Single Use Preloaded Sphincterotome V (Distal Wireguided) adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2026Material Fragmentation
IT WAS REPORTED THE SINGLE-USE PRELOADED SPHINCTEROTOME'S ISOLATION [KNIFE WIRE] WAS HANGING LOOSE. THIS OCCURRED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24944584 ↗MalfunctionApr 8, 2026Difficult to Insert
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24823649 ↗MalfunctionMar 19, 2026Break
IT WAS REPORTED THE SINGLE USE PRELOADED SPHINCTEROTOME V EXHIBITED THE CUTTING WIRE BROKE ON THE SECOND PASS. THE ISSUE OCCURRED DURING A THERAPEUTIC GASTROINTESTINAL ENDOSCOPY /RETROGRADE CATHETERIZATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641158 ↗MalfunctionFeb 17, 2026Material Twisted/Bent; Inadequate Lubrication
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE DISTAL WIREGUIDE EXHIBITED AN UNCOATED AREA ON THE GUIDE WIRE, AND THE INSERTION PORTION WAS BUCKLED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24369631 ↗MalfunctionFeb 11, 2026Break
IT WAS REPORTED THE SINGLE USE PRELOADED SPHINCTEROTOME'S WIRE BROKE. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24315832 ↗MalfunctionDec 26, 2025Break; Break
IT WAS REPORTED THE SINGLE-USE SPHINCTEROTOME'S WIRE BURNT THROUGH/SNAPPED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23896882 ↗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 ↗MalfunctionDec 19, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE USE PRELOADED SPHINCTEROTOME V THE COATED PORTION OF THE CUTTING WIRE WAS SCORCHED AND MELTED AT PROXIMAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 23853991 ↗MalfunctionDec 18, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23844363 ↗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 ↗MalfunctionSep 12, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23037767 ↗
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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