Instinct G18343Recalls & reported problems

Summary

The FDA's MAUDE database contains 244 adverse event reports that list this exact device (DI 00827002183438), received between Feb 19, 2016 and Jun 26, 2025 — classified as 21 injuries, 223 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (109 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 25 most recent of 244 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Use of Device Problem; Premature Separation; Use of Device Problem; Premature Separation

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. IT WAS REPORTED THAT THE CLIP WAS RELEASED PREMATURELY BY REMOVING IT FROM THE STERILE PACKAGING AND ATTEMPTING TO POSITION IT IN THE WORKING CHANNEL OF THE ENDOSCOPE, WITHOUT PUTTING PRESSURE ON THE ACTIVATION MECHANISM [PREMATURE DEPLOYMENT IN THE SCOPE]. 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 22338409 ↗
• MalfunctionMar 5, 2025Material Separation; Difficult to Open or Close; Material Separation; Difficult to Open or Close

  DURING A MUCOSECTOMY, THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT AT THE MOMENT OF USE, THE CLAMP [CLIP] WAS NOT ACTIVATED AND THE CLICK [CLIP] CAME OUT [THROMBOSING: CLIP HOUSING DETACHES FROM THE CATH ATTACH AND REMAINS ATTACHED TO THE DRIVE WIRE], TWO ATTEMPTS WERE MADE WHICH WERE UNSUCCESSFUL. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21525628 ↗
• MalfunctionMar 4, 2025Premature Separation; Premature Separation

  THIS FOLLOW UP EMDR IS BEING SENT TO CANCEL THE INITIAL EMDR SENT ON THIS EVENT. SEE H11 FOR MORE DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21514543 ↗
• MalfunctionJan 10, 2025Use of Device Problem; Premature Separation; Use of Device Problem; Premature Separation

  DURING CLIPPING FOR BLEEDING IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. IT WAS INITIALLY REPORTED THAT THE CLIP WAS FOUND TO BE DEFECTIVE DURING DEPLOYMENT HENCE IT WAS NOT USED. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024 INDICATED THAT THE CLIP TROMBONED [CLIP HOUSING DETACHED FROM THE CATH ATTACH AND REMAINED ATTACHED TO THE DRIVE WIRE]. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21123971 ↗
• MalfunctionJan 6, 2025Premature Separation; Premature Separation

  IN PREPARATION FOR A CLIPPING PROCEDURE, THE PHYSICIAN SELECTED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. IT WAS INITIALLY REPORTED THAT AS SOON AS THE CLIP WAS REMOVED FROM THE PACKAGE THE CLIP WAS FOUND TO BE DETACHED FROM THE CATHETER. THIS WAS INITIALLY INTERPRETED AS PREMATURE DEPLOYMENT IN THE CLOSED POSITION BECAUSE THE CLIP IS PACKAGED IN THE CLOSED POSITION. PREMATURE CLIP DEPLOYMENT IN THE CLOSED POSITION HAS NOT HISTORICALLY CAUSED OR CONTRIBUTED TO A SERIOUS INJURY NOR DEATH TO THE PATIENT, THEREFORE THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 10 DEC 2024 STATED THAT THE CLIP WAS OPEN WHEN DEPLOYED. [SUBJECT OF REPORT] THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079834 ↗
• MalfunctionFeb 1, 2024Premature Separation; Premature Separation

  DURING THE DIGESTIVE ENDOSCOPY EXAMINATION, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. IT WAS REPORTED THAT WHEN THE USER INTRODUCED THE DEVICE INTO THE WORKING CHANNEL IT SHOWED LITTLE RESISTANCE AND THE CLIP RELEASED WITHOUT IT HAVING BEEN FIRED [CLIP DEPLOYED DURING ADVANCEMENT THROUGH THE SCOPE - SUBJECT OF REPORT]. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18623298 ↗
• MalfunctionJan 30, 2024Premature Separation; Premature Separation

  DURING A DIGESTIVE ENDOSCOPY EXAMINATION, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. IT WAS REPORTED THAT THE USER INTRODUCED THE DEVICE CATHETER TO CLOSE THE LESION BUT THE CLIP LEFT THE WORKING CHANNEL AND, WHEN OPENED, IT DEPLOYED [PREMATURE DEPLOYMENT, OPEN POSITION]. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18605346 ↗
• MalfunctionJan 4, 2024Premature Separation; Premature Separation

  DURING HEMOSTASIS IN THE DUODENUM, THE PHYSICIAN USED AN INSTINCT ENDOSCOPIC HEMOCLIP. IT WAS REPORTED THAT THE CLIP DID NOT CLOSE AND WAS RELEASED FROM THE SYSTEM. DURING THE PROCEDURE, 4 HEMOCLIPS WERE USED WITHOUT ANY COMPLICATIONS. THE DOCTOR REMOVED THE CLIP WITH A FOREIGN BODY REMOVAL NET. 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: Foreign Body In Patient

  MAUDE report 18445161 ↗
• MalfunctionJan 3, 2024Premature Separation; Premature Separation

  DURING THE UPPER DIGESTIVE ENDOSCOPY PROCEDURE WITH MUCOSECTOMY, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. IT WAS REPORTED THAT WHEN POSITIONING THE CLIP, IT FIRED DECEPTIVELY [PREMATURELY DEPLOYED IN THE UNKNOWN POSITION]. THE CLIP WAS REMOVED WITH BIOPSY FORCEPS. 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 18436989 ↗
• MalfunctionDec 19, 2023Use of Device Problem; Premature Separation; Use of Device Problem; Premature Separation

  DURING A MUCOSECTOMY IN THE COLON, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. IT WAS REPORTED THAT THE CLIP DETACHED FROM THE TRIGGER SYSTEM BEFORE BEING ACTIVATED, DURING PASSAGE THROUGH THE COLONOSCOPE, AND IT WAS SEEN THAT IT CAME LOOSE AFTER PASSING THE ENTIRE INSTRUMENT THROUGH THE WORKING CHANNEL. THE PROCEDURE WAS COMPLETED USING ANOTHER CLIP. ADDITIONAL QUESTIONS WERE RECEIVED ON 16JAN2024 STATING THAT THE HANDLE SPOOL WAS HELD DURING PASSAGE OF THE DEVICE THROUGH THE WORKING CHANNEL. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18360602 ↗
• InjuryNov 16, 2023Premature Separation; Premature Separation

  DURING PROCEDURE FOR HEMOSTASIS IN THE STOMACH, THE PHYSICIAN USED TWO INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES. IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE CLIPS THEY PRE-MATURELY DEPLOYED [OPEN POSITION]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. HE USED HEMOSPRAY AND THE PROCEDURE WAS SUCCESSFUL. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient; Gastrointestinal Hemorrhage

  MAUDE report 18155386 ↗
• InjuryNov 16, 2023Separation Failure; Failure to Fire; Separation Failure; Failure to Fire

  DURING PROCEDURE FOR HEMOSTASIS IN THE STOMACH, THE PHYSICIAN USED TWO INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES. IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE CLIPS ON THE STOMACH OF THE PATIENT THE CLIPS WERE STUCK AND UNABLE TO BE DEPLOYED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. HE USED HEMOSPRAY AND THE PROCEDURE WAS SUCCESSFUL. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 18149488 ↗
• MalfunctionOct 11, 2023Material Separation; Difficult to Open or Close; Material Separation; Difficult to Open or Close

  DURING A POLYP CLIPPING, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. IT WAS REPORTED THAT THE DRIVE WIRE ADVANCED BUT RETRACTED WHEN ATTEMPTING TO OPEN CLIP [MOVED IN A TROMBONING MOTION]. THIS DEVICE WAS REMOVED AND DISCARDED. ANOTHER CLIP WAS USED TO COMPLETE THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17912306 ↗
• MalfunctionAug 11, 2023Separation Failure; Failure to Fire; Separation Failure; Failure to Fire

  DURING AN UNSPECIFIED PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. IT WAS REPORTED THAT THE CLIP DID NOT DEPLOY WHEN INSIDE THE PATIENT. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17512046 ↗
• MalfunctionAug 3, 2023Premature Separation; Premature Separation

  THIS FOLLOW UP EMDR IS BEING SENT TO CANCEL THE INITIAL EMDR SENT ON THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17449729 ↗
• MalfunctionAug 2, 2023Premature Separation; Premature Separation

  DURING A MUCOSECTOMY IN THE COLON, THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT WHEN INTRODUCING THE DEVICE THROUGH THE WORKING CHANNEL, THE CLIP WAS DETACHED, LEAVING ONLY THE CATHETER. ANOTHER 2 COOK MEDICAL INSTINCT CLIPS WERE USED. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATIONS. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17441989 ↗
• MalfunctionJul 26, 2023Premature Separation; Premature Separation

  IN PREPARATION FOR CLIPPING OF AN UPPER GI BLEED, THE PHYSICIAN PREPARED TO USE A COOK INSTINCT ENDOSCOPIC HEMOCLIP. IT WAS REPORTED THAT WHEN THE DEVICE WAS REMOVED FROM PACKAGING, THE CLIP SLIPPED OFF ON TESTING EVEN BEFORE PASSING TO THE SURGEON. THIS WAS INITIALLY INTERPRETED AS PREMATURE DEPLOYMENT CLOSED POSITION WHICH HAS NOT HISTORICALLY REQUIRED INTERVENTION TO PRECLUDE DEATH OR SERIOUS INJURY. ON (B)(6), 2023 ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THE CLIP DEPLOYED IN THE OPEN POSITION WHICH IS A REPORTABLE MALFUNCTION FOR THE POTENTIAL TO REQUIRE INTERVENTION TO PRECLUDE DEATH OR SERIOUS INJURY. THE USER HAD TO USE ANOTHER TO COMPLETE THE PROCEDURE. 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 17400277 ↗
• MalfunctionJul 26, 2023Failure to Fire; Failure to Fire

  DURING A POLYPECTOMY IN THE DESCENDING COLON, THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT THE CLIP DID NOT DETACH FROM THE DEPLOYMENT SYSTEM. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17395581 ↗
• MalfunctionJun 19, 2023Premature Separation; Premature Separation

  DURING AN UNSPECIFIED PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. IT WAS REPORTED THAT THE CLIP RELEASED BEFORE BEING TRIGGERED [PREMATURE DEPLOYMENT IN UNKNOWN POSITION]. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17151278 ↗
• InjuryJun 8, 2023Premature Separation; Premature Separation

  DURING HEMOSTASIS PROCEDURE IN THE STOMACH, THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT THE CLIP PREMATURELY DEPLOYED IN THE OPEN POSITION. THE PHYSICIAN USED HEMOSPRAY TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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, HOWEVER, HEMOSPRAY WAS USED TO FINISH THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 17090211 ↗
• InjuryJun 8, 2023Separation Failure; Failure to Fire; Separation Failure; Failure to Fire

  DURING HEMOSTASIS PROCEDURE IN THE STOMACH, THE PHYSICIAN USED THREE COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES. IT WAS REPORTED THAT THE CLIPS WERE STUCK AND UNABLE TO BE DEPLOYED. 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, HOWEVER, HEMOSPRAY WAS USED TO FINISH THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 17090112 ↗
• MalfunctionMay 19, 2023Premature Separation; Premature Separation

  DURING A COLONOSCOPY IN DESCENDING COLON AFTER POLYP REMOVAL, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. IT WAS REPORTED THAT THE NURSING TECHNICIAN INSERTED THE CLIP THROUGH THE WORKING CHANNEL AND OBSERVED THAT IT WENT OFF BY ITSELF IN THE PASSAGE [WITHIN THE SCOPE], EVEN THOUGH SHE KEPT THE HANDLE OPEN. SHE COLLECTED THE TRIGGERED [DEPLOYED] CLIP AS IT REMAINED IN THE WORKING CHANNEL. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16960404 ↗
• MalfunctionApr 28, 2023Use of Device Problem; Premature Separation; Use of Device Problem; Premature Separation

  DURING AN ENDOSCOPIC PROCEDURE TO STOP ARTERIAL BLEEDING IN THE FUNDUS. THE PHYSICIAN USED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED, THAT WHEN THE DISTAL PART OF THE CLIP APPEARED IN THE ENDOSCOPY IMAGE, ITS TIP PART WAS PARTIALLY DETACHED FROM THE CATHETER [MOVED IN A TROMBONING MANNER] (REPORTED UNDER 1037905-2023-000830. MULTIPLE DEVICES FROM VARIOUS LOTS WERE RETURNED AND PER REP RESPONSE RECEIVED 04/05/2023. "THEY RETURNED ALL THE CLIPS USED IN [THIS] PROCEDURE, BECAUSE THEY WERE NOT SURE IF THE PROBLEM WAS DUE TO A MANUFACTURING ERROR. THERE WERE DIFFICULTIES WITH ALL THE RETURNED CLIPS. AFTER DISCUSSING WITH THEM, IT BECAME CLEAR, THAT IT WAS APPARENTLY A HANDLING ERROR AND I HAVE GIVEN THEM A NEW IN-SERVICE". THESE ADDITIONAL CLIPS ARE FROM LOT W4589669 AND ARE CAPTURED UNDER THIS REPORT. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16831592 ↗
• MalfunctionFeb 16, 2023Premature Separation; Premature Separation

  DURING A MUCOSECTOMY, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. IT WAS REPORTED THAT THAT THE CLIP WAS LOOSE. A PHOTO WAS PROVIDED THAT SHOWS THE DEVICE WITHOUT THE CLIP ATTACHED TO THE DELIVERY SYSTEM. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16385595 ↗
• MalfunctionJan 11, 2023Premature Separation; Premature Separation

  DURING AN UPPER DIGESTIVE ENDOSCOPY, THE PHYSICIAN USED TWO COOK INSTINCT ENDOSCOPIC HEMOCLIPS. IT WAS REPORTED THAT THE CUSTOMER REPORTED THAT HE TRIED TO USE 2 DEVICES, BUT THEY DID NOT PASS THROUGH THE CHANNEL. TWO PHOTOS WERE PROVIDED, WITH ONE SHOWING A DEVICE OUTSIDE OF THE ENDOSCOPE WITH THE CLIP MISSING (PREMATURE DEPLOYMENT IN AN UNKNOWN POSITION; SUBJECT OF REPORT). IT WAS REPORTED THAT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16136829 ↗