DISPOSABLE TRIPLE LUMEN SPHINCTEROTOMERecalls & reported problems across all models

We found 9 models of DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Oct 8, 2020 and Oct 21, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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

DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME 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-1294-2026 · 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-1293-2026 · 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-1289-2026 · 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-1288-2026 · 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-1287-2026 · 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-1286-2026 · 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-1270-2026 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

Most reported DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME problems

DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME models

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

• DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-401Q-0320

  Unit, electrosurgical, endoscopic (with or without accessories)
  2 recalls1 report
• DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-401Q-0730

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall3 reports
• DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-431Q-0720

  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
  1 recall1 report
• DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-401Q-0330

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall0 reports
• DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-401Q-0720

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall0 reports
• DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-431Q-0720

  Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall0 reports
• DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-411Q-0730

  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
  1 recall0 reports
• DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-431Q-0720

  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
  1 recall0 reports
• DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-411Q-0320

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

Recent DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347617 ↗
• MalfunctionMar 17, 2023Break; Break

  THE CUSTOMER REPORT TO OLYMPUS THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), IT WAS REPORTED THAT THE SPHINCTERTOME WIRE SNAPPED. THE PROCEDURE WAS EXTENDED AN ADDITIONAL TEN MINUTES TO LOCATE THE WIRE THAT WAS POSSIBLY LODGED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. NO ADDITIONAL TREATMENT WAS REQUIRED. THERE WAS NO REPORTED PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564309 ↗
• MalfunctionJan 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A CUSTOMER REPORTED TO OLYMPUS THAT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THIS DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME WAS DISLODGED INTO THE PATIENT. IT WAS NOT CONFIRMED WHERE IT WENT AND WAS NOT RETRIEVED FROM THE PATIENT OR THE SCOPE. AN XRAY WAS PERFORMED AFTER THE PROCEDURE AND THE PHYSICIAN CANNOT CONFIRM ANY NEEDLE WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134154 ↗
• MalfunctionJun 16, 2022Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn

  AS REPORTED, DURING AN ENDOSCOPIC CHOLANGIO-PANCREATOGRAPHY THERAPEUTIC PROCEDURE, AT THE TIME OF THE SPHINCTEROTOMY OF THE ODDI SPHINCTER, THE WIRE IS CUT BY THE ELECTRIC ARC OF THE KNIFE. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SPHINCTEROTOME (SIMILAR DEVICE) FROM THE SAME LOT WITHOUT ANY ISSUE. NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14710619 ↗
• MalfunctionMay 13, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM OLYMPUS (B)(4) THAT DURING SPHINCTEROTOMY PROCEDURE USING THE SUBJECT DEVICE, WHEN THE CUTTING KD WIRE BROKE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822988 ↗
• MalfunctionOct 8, 2020Break; Break

  WE RECEIVED THE FOLLOWING REPORT. DURING A BILIARY PROCEDURE AND PAPILLA CUTTING, THE SUBJECT DEVICE WAS USED. THE CUTTING WIRE BROKE. ANOTHER DEVICE WAS THEN USED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. ON SEPTEMBER 16, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE CUTTING WIRE WAS BROKEN OFF, AND THAT THE BROKEN SECTION OF THE CUTTING WIRE WAS MELTED AND BURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10653557 ↗

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