Huibregtse G24885Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002248854), received between Apr 21, 2017 and Mar 18, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Material Fragmentation; Material Fragmentation

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE. IT WAS REPORTED THAT DURING THE PAPILLOTOMY, THE NEEDLE FELL OFF. ACCORDING TO THE INITIAL REPORTER, A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE NEEDLE TIP COULDN'T BE RETRIEVED AS THE OBJECT MOVED DUE TO PERISTALSIS DIRECTLY INTO JEJUNUM. NO FURTHER INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, AND IT WAS STATED THAT THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21634338 ↗
• InjuryFeb 19, 2020Device Fell

  PHYSICIAN WAS USING HPC-3 HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE DURING A PROCEDURE. THE NEEDLE KNIFE DROPPED OFF AND FELL INTO THE PT. PHYSICIAN VISUALIZED IT AND WAS ABLE TO REMOVE IT USING FORCEPS THROUGH THE EGD SCOPE. NO PT INJURY OR EXTRA PROCEDURE OR RECOVERY TIME NEEDED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9734016 ↗
• InjurySep 28, 2018Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE(S). THE PATIENT HAD A DIFFICULT PAPILLA. SO, THE PHYSICIAN DECIDED TO CUT [THE PAPILLA] WITH A NEEDLE KNIFE. WHILE CUTTING, THE TIP [OF THE NEEDLE KNIFE] BROKE OFF INSIDE THE PAPILLA. IT [THE BROKEN TIP] WAS RETRIEVED WITH FORCEPS. THE SECOND DEVICE ALSO BROKE IN FRONT OF THE PAPILLA; THE TIP WAS ALSO RETRIEVED. WITH THE THIRD DEVICE, THE PROCEDURE WAS FINISHED. OVERALL, THREE (3) DEVICES WERE USED ON THE PATIENT, TWO (2) FAILED AND ONE (1) WAS SUCCESSFUL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE DETACHED PORTIONS OF THE NEEDLE KNIVES WERE RETRIEVED WITH FORCEPS DUE TO THESE OCCURRENCES. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 7918539 ↗
• InjuryJun 29, 2018Break; Use of Device Problem; Break; Use of Device Problem

  THE FOLLOWING WAS REPORTED TO THE FDA ON 29-JUNE-2018: "DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE. WHILE THE PHYSICIAN WAS USING THE PRODUCT AND SENDING A CURRENT, AT THE END OF THE PROCEDURE, THE NEEDLE WAS ATTACHED TO THE PAPILLA. THE PHYSICIAN REMOVED IT [THE NEEDLE] WITH A FORCEPS. INSIDE THE PATIENT THERE WAS NOTHING LEFT [BEHIND]. CLARIFICATION WAS RECEIVED ON 12-JUNE-2018: WHILE CUTTING, THE NEEDLE BROKE AND THEN DETACHED INTO THE PAPILLA." ADDITIONAL INFORMATION WAS RECEIVED ON 02-JULY-2018 INDICATING THE USER HELD THE NEEDLE KNIFE STATIONARY WHEN CURRENT WAS APPLIED. A PORTION OF THE NEEDLE KNIFE DETACHED INSIDE OF THE PATIENT AND WAS RETRIEVED WITH BIOPSY FORCEPS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 7652313 ↗
• MalfunctionApr 21, 2017Material Disintegration; Off-Label Use; Material Disintegration; Off-Label Use

  DURING AN ENDOSCOPIC PROCEDURE TO CUT THE ZENKER DIVERTICULUM, PHYSICIAN USED A COOK HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE. DURING THE CUTTING PROCEDURE, THE NEEDLE WIRE DISINTEGRATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6511794 ↗