Huibregtse G22037Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002220379), received between Aug 26, 2016 and Jun 6, 2019 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2019Fracture; Fracture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK HUIBREGTSE NEEDLE KNIFE PAPILLOTOME. THE DEVICE FELL APART AND IS IN PIECES. ALL THE PIECES WERE RETRIEVED. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 05/29/2019: THE TIP OF THE DEVICE FELL OFF INTO PATIENT AND WAS RETRIEVED WITH FORCEPS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE DETACHED PORTION OF THE DEVICE WAS RETRIEVED WITH FORCEPS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8676210 ↗
• MalfunctionMay 15, 2019Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK HUIBREGTSE NEEDLE KNIFE PAPILLOTOME. PER THE USER, THE NEEDLE TIP WAS BROKEN INSIDE THE PATIENT [NEEDLE BROKE WHILE BEING USED]. THE DEVICE WAS RECEIVED FOR EVALUATION AND AN ESTIMATED PORTION OF 3 MM DETACHED FROM THE DEVICE OR DISINTEGRATED. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. THE DEVICE WAS RETURNED WITH A THE NEEDLE KNIFE BROKEN AND AN ESTIMATED 3MM PORTION WAS NOT INCLUDED IN THE RETURN. THE LOCATION OF THE MISSING PORTION IS UNKNOWN. THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS, IF ANY DEVICE PORTION REMAINED IN THE PATIENT, OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8612949 ↗
• MalfunctionJun 19, 2018Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK HUIBREGTSE NEEDLE KNIFE PAPILLOTOME. THE NEEDLE FELL OFF THE CATHETER WHILE IN THE PATIENT (PREPARING TO CUT THE MUCOSA). RECEIVED 31-MAY-2018: THE NEEDLE KNIFE WAS OBSERVED FALLING OFF IN THE PATIENT. ONE OF THEM BROKE OFF BEFORE CURRENT WAS APPLIED (SEE RELATED MDR 1037905-2018-00267). THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED PER A PHONE CALL WITH THE AREA CLINICAL SPECIALIST: THE CLINICAL SPECIALIST WAS NOT IN THE CASE WHEN THE NEEDLES DETACHED, SO IT IS UNKNOWN IF THE NEEDLE KNIFES WERE HELD STATIONARY WHEN CURRENT WAS APPLIED. IN PREVIOUS PROCEDURES THE CLINICAL SPECIALIST HAS BEEN IN, THEY MOVED THE NEEDLE WHEN MAKING CUTS. THE FIRST NEEDLE BROKE WHEN APPLYING CURRENT (SEE RELATED MDR 1037905-2018-00266). A SECOND NEEDLE KNIFE WAS THEN USED AND IT BROKE BEFORE CURRENT WAS APPLIED (SEE RELATED MDR 1037905-2018-00267). A THIRD NEEDLE KNIFE WAS THEN USED AND IT ALSO BROKE WHEN APPLYING CURRENT (SUBJECT OF THIS REPORT), AND A FOURTH NEEDLE WAS USED TO FINISH THE PROCEDURE. IT WAS A DIFFICULT POSITION AND THE NEEDLES WERE CLOSE TO THE ENDOSCOPE. OTHER THAN THE DETACHED PORTION OF TH

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

  MAUDE report 7616117 ↗
• MalfunctionJun 19, 2018Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK HUIBREGTSE NEEDLE KNIFE PAPILLOTOME. THE NEEDLE FELL OFF THE CATHETER WHILE IN THE PATIENT (PREPARING TO CUT THE MUCOSA). RECEIVED 31-MAY-2018: THE NEEDLE KNIFE WAS OBSERVED FALLING OFF IN THE PATIENT. ONE OF THEM BROKE OFF BEFORE CURRENT WAS APPLIED (SEE RELATED MDR 1037905-2018-00267). THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED PER A PHONE CALL WITH THE AREA CLINICAL SPECIALIST: THE CLINICAL SPECIALIST WAS NOT IN THE CASE WHEN THE NEEDLES DETACHED, SO IT IS UNKNOWN IF THE NEEDLE KNIFES WERE HELD STATIONARY WHEN CURRENT WAS APPLIED. IN PREVIOUS PROCEDURES THE CLINICAL SPECIALIST HAS BEEN IN, THEY MOVED THE NEEDLE WHEN MAKING CUTS. THE FIRST NEEDLE BROKE WHEN APPLYING CURRENT (SUBJECT OF THIS REPORT). A SECOND NEEDLE KNIFE WAS THEN USED AND IT BROKE BEFORE CURRENT WAS APPLIED (SEE RELATED MDR 1037905-2018-00267). A THIRD NEEDLE KNIFE WAS THEN USED AND IT ALSO BROKE WHEN APPLYING CURRENT (SEE RELATED MDR 1037905-2018-00268), AND A FOURTH NEEDLE WAS USED TO FINISH THE PROCEDURE. IT WAS A DIFFICULT POSITION AND THE NEEDLES WERE CLOSE TO THE ENDOSCOPE. OTHER THAN THE DETACHED PORTION OF TH

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

  MAUDE report 7616094 ↗
• MalfunctionJun 19, 2018Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK HUIBREGTSE NEEDLE KNIFE PAPILLOTOME. THE NEEDLE FELL OFF THE CATHETER WHILE IN THE PATIENT (PREPARING TO CUT THE MUCOSA). RECEIVED 31-MAY-2018: THE NEEDLE KNIFE WAS OBSERVED FALLING OFF IN THE PATIENT. ONE OF THEM BROKE OFF BEFORE CURRENT WAS APPLIED (SUBJECT OF THIS REPORT). THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED PER A PHONE CALL WITH THE AREA CLINICAL SPECIALIST: THE CLINICAL SPECIALIST WAS NOT IN THE CASE WHEN THE NEEDLES DETACHED, SO IT IS UNKNOWN IF THE NEEDLE KNIFES WERE HELD STATIONARY WHEN CURRENT WAS APPLIED. IN PREVIOUS PROCEDURES THE CLINICAL SPECIALIST HAS BEEN IN, THEY MOVED THE NEEDLE WHEN MAKING CUTS. THE FIRST NEEDLE BROKE WHEN APPLYING CURRENT (SEE RELATED MDR 1037905-2018-00266). A SECOND NEEDLE KNIFE WAS THEN USED AND IT BROKE BEFORE CURRENT WAS APPLIED (SUBJECT OF THIS REPORT). A THIRD NEEDLE KNIFE WAS THEN USED AND IT ALSO BROKE WHEN APPLYING CURRENT (SEE RELATED MDR 1037905-2018-00268), AND A FOURTH NEEDLE WAS USED TO FINISH THE PROCEDURE. IT WAS A DIFFICULT POSITION AND THE NEEDLES WERE CLOSE TO THE ENDOSCOPE. OTHER THAN THE DETACHED PORTION OF THE DEVICE, A

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

  MAUDE report 7615209 ↗
• InjurySep 2, 2016Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK HUIBREGTSE NEEDLE KNIFE PAPILLOTOME. DURING THE PRE-CUT SPHINCTEROTOMY, THE NEEDLE TIP BROKE OFF. ON 08/11/2016, THE FOLLOWING WAS RECEIVED: "THE NEEDLE TIP BROKE OFF DURING USE OF THE ALBARRAN LEVER [ENDOSCOPE ELEVATOR] AND WAS RETRIEVED BY FORCEPS." ON 08/24/2016, WE RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: "THE PHYSICIAN SAID THAT IT MIGHT HAVE HAPPENED WHILE TIGHTENING THE ALBARRAN LEVER [ENDOSCOPE ELEVATOR] BUT IT ISN'T POSSIBLE TO GET CERTAIN INFORMATION FROM THE DEPARTMENT."

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

  MAUDE report 5925208 ↗
• InjuryAug 26, 2016Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE PHYSICIAN USED A COOK HUIBREGTSE NEEDLE KNIFE PAPILLOTOME. THIS INFORMATION WAS PROVIDED BY THE CUSTOMER TO THE COOK REPRESENTATIVE: "THE NEEDLE KNIFE WAS FOUND TO BE DETACHED FROM THE SYSTEM UPON USING IT ON THE PATIENT. THE PROCEDURE WAS CONTINUED WITHOUT USING A NEW NEEDLE KNIFE, AND WAS SUCCESSFUL." PER CLARIFICATION RECEIVED FROM THE COOK REPRESENTATIVE ON 08/08/2016: "THE NEEDLE KNIFE WAS FOUND DETACHED FROM THE SYSTEM. THE DOCTOR USED BIOPSY FORCEPS TO RETRIEVE THE DETACHED PART FROM PATIENT'S DUODENUM REGION."

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

  MAUDE report 5906186 ↗