Instinct G24653Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002246539), received between Apr 7, 2017 and Apr 25, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2022Premature Separation; Premature Separation

  DURING A GASTROSCOPY OF THE STOMACH, A COOK INSTINCT ENDOSCOPIC HEMOCLIP WAS USED. WHILE THE USER WAS ATTEMPTING TO CLOSE THE CLIP, IT DISENGAGED FROM THE CATHETER AND THE DOCTOR USED ANOTHER CLIP TO COMPLETE THE PROCEDURE [PREMATURE DEPLOYMENT IN THE OPEN POSITION]. ADDITIONAL INFORMATION RECEIVED STATES THE CLIP DEPLOYED IN THE OPEN POSITION. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14195311 ↗
• MalfunctionFeb 25, 2021Premature Separation; Premature Separation

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE CLIP WAS OPEN IN THE WORKING CHANNEL OF THE ENDOSCOPE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. CLARIFICATION WAS RECEIVED ON 02FEB21 THAT INDICATES THE CLIP PREMATURELY DEPLOYED IN THE OPEN POSITION IN THE ENDOSCOPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11378980 ↗
• MalfunctionAug 10, 2018Break; Break

  DURING A CLIPPING PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE CLIP DEPLOYED PREMATURELY AFTER THE CATHETER WAS IN POSITION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CLIP PREMATURELY DEPLOYED DURING ADVANCEMENT THROUGH THE ENDOSCOPE. ACCORDING TO THE PHYSICIAN, WHEN [THEY] ATTEMPTED TO OPEN THE CLIP, ONE OF THE "TINES" BROKE. CLARIFYING INFORMATION RECEIVED INDICATED THAT THE "DOCTOR RESPONDED BACK AND WAS REFERRING TO THE 'CLIP ARM' AND NOT THE NITINOL STRIP. ALSO, THE DOCTOR NOTED THAT NOTHING WAS LEFT BEHIND IN THE PATIENT AS IT [THE DEVICE] WAS IMMEDIATELY REMOVED. PLEASE NOTE, THEY DON¿T EXACTLY KNOW WHEN OR HOW THE CLIP ARM BROKE. [IT WAS] MOST LIKELY OUTSIDE THE PATIENT WHEN EXAMINING THE CLIP. THERE ARE LOTS OF UNCERTAINTIES IN THE PHYSICIAN'S FOLLOW-UP, AS STAFF ARE NOT FAMILIAR WITH OVER-ALL FUNCTIONING OF THE INSTINCT CLIP." FURTHER INFORMATION WAS RECEIVED NOTING THAT THE ENDOSCOPE WAS TORQUED/ANGLED AND IN THE DISTAL DUODENUM CONTROLLING A BLEED. THE INSTINCT CLIP WAS CHECKED BEFORE USING WITH CLOSING AND OPENING THE CLIP. WHEN THE CLIP WAS ADVANCED DOWN THE ACCESSORY CHANNEL OF THE ENDOSCOPE AND IN POSITION FOR USE, IT WAS AT T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7773519 ↗
• MalfunctionApr 7, 2017Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE CLIP PREMATURELY DEPLOYED IN THE SCOPE AS IT WAS BEING ADVANCED TOWARD THE PATIENT. THE CLIP WAS LEFT IN THE PATIENT TO PASS NATURALLY.

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

  MAUDE report 6471667 ↗