Single Use Sphincterotome V(Distal Wireguided)Recalls & reported problems across all models

We found 15 models of Single Use Sphincterotome V(Distal Wireguided) by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2019 and Jul 23, 2024 — classified as 9 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (16 reports).

7 FDA recall records name at least one of these models by its device identifier, 7 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(Distal Wireguided) 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-1282-2026 · 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-1281-2026 · Root cause: Process control · Recall details · FDA record ↗

3. Jan 7, 2026Open, Classified

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

   Z-1280-2026 · Root cause: Process control · Recall details · FDA record ↗

4. Jan 7, 2026Open, Classified

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

   Z-1279-2026 · Root cause: Process control · Recall details · FDA record ↗

5. Jan 7, 2026Open, Classified

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

   Z-1278-2026 · Root cause: Process control · Recall details · FDA record ↗

6. Jan 7, 2026Open, Classified

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

   Z-1277-2026 · Root cause: Process control · Recall details · FDA record ↗

7. Jan 7, 2026Open, Classified

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

   Z-1269-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported Single Use Sphincterotome V(Distal Wireguided) problems

Single Use Sphincterotome V(Distal Wireguided) models

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

• Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0720

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall7 reports
• Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0330

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall1 report
• Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0730

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall1 report
• Single Use Sphincterotome V(Distal Wireguided) KD-VC412Q-0215

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall0 reports
• Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0320

  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
  1 recall0 reports
• Single Use Sphincterotome V(Distal Wireguided) KD-VC431Q-0720

  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
  1 recall0 reports
• Single Use Sphincterotome V(Distal Wireguided) KD-VC431Q-0730

  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
  1 recall0 reports
• Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0720

  Unit, electrosurgical, endoscopic (with or without accessories)
  5 reports
• Single Use Sphincterotome V(Distal Wireguided) KD-VC412Q-0215

  Unit, electrosurgical, endoscopic (with or without accessories)
  5 reports
• Single Use Sphincterotome V(Distal Wireguided) KD-VC431Q-0720

  Unit, electrosurgical, endoscopic (with or without accessories)
  4 reports
• Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0320

  Unit, electrosurgical, endoscopic (with or without accessories)
  3 reports
• Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0730

  Unit, electrosurgical, endoscopic (with or without accessories)
  3 reports
• Single Use Sphincterotome V (Distal Wireguided) KD-VC431Q-0730

  Unit, electrosurgical, endoscopic (with or without accessories)
  2 reports
• Single Use Sphincterotome V(Distal Wireguided) KD-VC411Q-0330

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 report
• Single Use Sphincterotome V(Distal Wireguided) KD-VC431Q-0720

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

Recent Single Use 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.

• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED, THE SINGLE USE PRELOADED SPHINCTEROTOME. THE KNIFE WIRE WAS BROKEN. THE ISSUE WAS FOUND, DURING AN ENDOSCOPIC SPHINCTEROTOMY THERAPEUTIC PROCEDURE. WHEN PERFORMING AN ELECTROCUTION, FOR PYLORUS RESECTION. THE DEVICE WAS REMOVED. AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806681 ↗
• MalfunctionJul 9, 2024Break; Break

  IT WAS REPORTED THAT THE WIRE OF THE SINGLE USE PRELOADED SPHINCTEROTOME BROKE WHEN ELECTRICITY WAS APPLIED. IT DID NOT FALL OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST) 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 19700848 ↗
• MalfunctionJul 5, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE SINGLE USE PRELOADED SPHINCTEROTOME EXHIBITED THE COVER WAS PEELED AND THE KNIFE WIRE WAS EXPOSED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19683608 ↗
• MalfunctionMay 9, 2024Break; Break

  IT WAS REPORTED THE SPHINCTEROTOME WAS PRELOADED AND THE CUTTING/CAUTER SNAPPED WHEN INITIATED. THE ISSUE OCCURRED DURING A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THE PATIENT WAS SEDATED AND THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281667 ↗
• MalfunctionMay 7, 2024Break; Break

  IT WAS REPORTED THE SPHINCTEROTOME EXPERIENCED SPLITTING OF THE CUTTING/CAUTER GUIDEWIRE. THE ISSUE OCCURRED DURING A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264980 ↗
• MalfunctionMar 2, 2024Break; Break

  IT WAS REPORTED THAT THE SPHINCTEROTOME V EXHIBITED A BREAKAGE OF THE CUTTING WIRE. THE ISSUE WAS FOUND DURING A THERAPEUTIC SPHINCTEROTOMY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18823384 ↗
• MalfunctionFeb 27, 2024Break; Break

  IT WAS REPORTED, THE IT WAS REPORTED, THE SINGLE USE SPHINCTEROTOME V'S CUTTING WIRE BROKE. THE ISSUE OCCURRED AT THE BEGINNING OF AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789976 ↗
• MalfunctionFeb 15, 2024Thermal Decomposition of Device; Melted; Material Split, Cut or Torn; Thermal Decomposition of Device; Melted; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COATED PORTION OF THE SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED) CUTTING WIRE WAS TORN, AND THE BROKEN PORTION WAS SCORCHED AND MELTED FROM TOUCHING METAL WHEN ACTIVATED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711213 ↗
• MalfunctionOct 27, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDE) FELL OFF. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022181 ↗
• MalfunctionSep 28, 2023Fracture; Fracture

  A CUSTOMER REPORTED TO OLYMPUS, DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY (EST), THE KNIFE WIRE TIP BROKE AT THE TIMING OF OUTPUT. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840813 ↗
• MalfunctionSep 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO OLYMPUS THE SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED) THE KNIFE WIRE WAS CUT AT THE TIMING OF ENERGIZATION. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC BILIARY ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17793934 ↗
• MalfunctionSep 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THE SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED) WIRE KNIFE BROKE WHEN THE HIGH-FREQUENCY DEVICE WAS ENERGIZED. THE REPORTED ISSUE OCCURRED DURING A THERAPEUTIC DUODENAL PAPILLOTOMY (EST). THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686689 ↗
• MalfunctionAug 24, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED) WAS INSPECTED BEFORE USE AND THE COVERING WAS TORN, EXPOSING THE KNIFE WIRE. THE ISSUE WAS FOUND DURING PROCEDURE, AND THE THERAPEUTIC PROCEDURE (ENDOSCOPIC SPHINCTEROTOMY) WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612540 ↗
• MalfunctionFeb 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AN OLYMPUS SALES REPRESENTATIVE (REP) REPORTED THAT HIS CUSTOMER EXPERIENCED AN OUT OF BOX FAILURE ON HIS OLYMPUS SINGLE-USE SPHINCTEROTOME V. ACCORDING TO THE REP, THE KNIFE WIRE FELL OFF UPON REMOVAL FROM THE PACKAGING. THIS EVENT HAD NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385142 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO ANY OF THE ADVERSE EVENTS, NOR MALFUNCTION DURING ANY OF THE PROCEDURES DESCRIBED IN THE ARTICLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16354841 ↗

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