Instinct G18344Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00827002183445), received between Jun 2, 2017 and Mar 22, 2021 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2021Premature Separation; Premature Separation

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE HEMOCLIP WAS ADVANCED THROUGH THE WORKING CHANNEL OF AN ENDOSCOPE AND WHEN OPENED THE CLIP PREMATURELY FELL OFF [IN THE OPEN POSITION]. THE PHYSICIAN LEFT THE CLIP IN THE PATIENT TO PASS NATURALLY. ANOTHER OF THE SAME HEMOCLIP, WAS USED TO CONTINUE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. THE CLIP REMAINED INSIDE THE PATIENT¿S BODY TO PASS NATURALLY. 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 11541704 ↗
• MalfunctionOct 5, 2020Use of Device Problem; Premature Separation; Use of Device Problem; Premature Separation

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED TWO (2) COOK INSTINCT ENDOSCOPIC PROCEDURE. THE TWO (2) CLIPS FELL OFF [CLIPS PREMATURELY DEPLOYED IN UNKNOWN POSITION]. ADDITIONAL INFORMATION WAS RECEIVED ON 25-SEP-2020 STATING AFTER THEY MOVED THE TWO CLIPS DOWN THE ENDOSCOPE, THEY TRIED TO DEPLOY THEM AND THEY FELL OFF PREMATURELY [IN AN OPEN POSITION]. THE TECHNICIAN USING THE DEVICE STATED SHE USED TENSION THE WHOLE TIME HAVING HER THUMB IN THE SPOOL AND APPLY PRESSURE THE ENTIRE TIME THE DEVICE WAS MOVED THROUGH THE ENDOSCOPE. IT IS UNKNOWN IF THE DEPLOYED CLIPS WERE LEFT TO PAS NATURALLY OR ELECTIVELY REMOVED. 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 10626354 ↗
• MalfunctionMay 7, 2020Separation Failure; Failure to Fire; Separation Failure; Failure to Fire

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE CLIP WOULD NOT DEPLOY AFTER CLOSING ON THE SITE. THE PHYSICIAN PULLED OUT THE CLIP. 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 10036550 ↗
• MalfunctionFeb 10, 2020Premature Separation; Premature Separation

  DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE PHYSICIAN ATTEMPTED TO OPEN THE CLIP AND THE CLIP DEPLOYED IN AN UNKNOWN POSITION. THE CLIP WAS LEFT TO PASS NATURALLY. THE CLIP REMAINED INSIDE THE PATIENT¿S BODY TO PASS NATURALLY. 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 9688886 ↗
• MalfunctionOct 21, 2019Premature Activation; Premature Activation

  DURING A CLIPPING PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOSTAT. THE FOLLOWING IS THE EVENT DESCRIPTION LISTED ON THE MAUDE REPORT (B)(4): "A CLIP DEPLOYED INSIDE SCOPE PRIOR TO USE. PHYSICIAN NOTED THAT WHILE HE WAS ADVANCING CLIP CATHETER DOWN THE BIOPSY CHANNEL HE MET SOME RESISTANCE AND WHEN THE CATHETER CAME THROUGH THE TIP OF THE SCOPE THAT THE CLIP WAS DETACHED." THE FOLLOWING WAS SELECTED ON THE MAUDE REPORT: "DATE REPORT TO MANUFACTURER: 08/08/2019"; HOWEVER, NO REPORTS OF THIS NATURE HAVE BEEN RECEIVED REGARDING THIS DEVICE WITH THE SAME RPN, LOT NUMBER, DATE OF EVENT, OR ANY COMBINATION OF AVAILABLE INFORMATION. WE ARE ATTEMPTING TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME FROM THE THREE USER FACILITIES FOUND TO HAVE PURCHASED THE LOT NUMBER LISTED ON THE MAUDE REPORT. WHILE THE MAUDE REPORT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION PUBLISHED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9216203 ↗
• MalfunctionAug 15, 2019Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  DURING A HEMOSTASIS PROCEDURE, THE PHYSICIAN USED AN INSTINCT ENDOSCOPIC HEMOCLIP. THE CLIP EXITED THE ENDOSCOPE TWO SECONDS BEFORE THE SHEATH [CLIP PREMATURELY DEPLOYS IN ENDOSCOPE CHANNEL]. THE SHEATH WAS NOT SAVED AND THE CLIP IS FLOATING INSIDE THE PATIENT. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED ON 02-AUG-2019: THE CLOSED CLIP DEPLOYED WHILE BEING ADVANCED THROUGH THE ENDOSCOPE CHANNEL. THE PREMATURELY DEPLOYED CLIP REMAINED IN THE PATIENT¿S BODY TO PASS NATURALLY. 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; No Consequences Or Impact To Patient

  MAUDE report 8898909 ↗
• MalfunctionAug 8, 2019Activation, Positioning or Separation Problem

  CLIP DEPLOYED INSIDE SCOPE PRIOR TO USE. PHYSICIAN NOTED THAT WHILE HE WAS ADVANCING CLIP CATHETER DOWN THE BIOPSY CHANNEL HE MET SOME RESISTANCE AND WHEN THE CATHETER CAME THROUGH THE TIP OF THE SCOPE THAT THE CLIP WAS DETACHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8873328 ↗
• MalfunctionAug 1, 2019Premature Activation; Premature Activation

  DURING A CLIPPING PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE PHYSICIAN WAS TRYING TO CLIP A FLAP DURING THE PROCEDURE, AND THE ENDOSCOPE WAS SO RETROFLEXED ALONG WITH THE ELEVATOR OF THE ENDOSCOPE, WHILE APPLYING PRESSURE TO THE CLIP CATHETER, THAT THE TECHNICIAN WAS UNABLE TO CLIP THE DESIRED SPOT. THE CLIP DEPLOYED PREMATURELY [OPEN]. THE PRODUCT WAS REMOVED BACK THROUGH THE ENDOSCOPE. A SECOND CLIP WAS ATTEMPTED TO BE PLACED. AT THIS POINT THE PROCEDURE WAS ABORTED. THE PHYSICIAN TOLD THE COOK SALES REPRESENTATIVE THAT "IT [THE MALFUNCTION] WAS DUE TO WHERE THEY WERE WORKING IN THE PATIENT AND WAS NOT DUE TO THE CLIP." THE PREMATURELY DEPLOYED CLIP REMAINED IN 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: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 8850284 ↗
• MalfunctionJun 13, 2019Premature Activation; Premature Activation

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE CLIP WOULD NOT OPEN. THE DEVICE WAS REMOVED AND THE PHYSICIAN USED ANOTHER CLIP TO FINISH THE PROCEDURE WITH NO FURTHER COMPLICATIONS. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION AT COOK ENDOSCOPY. IT WAS THEN FORWARDED TO THE APPROVED SUPPLIER FOR FURTHER EVALUATION. DURING THE FUNCTIONAL EVALUATION AT THE SUPPLIER, THE CLIP PREMATURELY DEPLOYED IN THE SUPPLIER'S ENDOSCOPE. THIS OCCURRED POST-PATIENT CONTACT AT THE SUPPLIER; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8697509 ↗
• MalfunctionJun 10, 2019Premature Activation; Premature Activation

  DURING AN ENDOSCOPIC PROCEDURE THE PHYSICIAN USED THREE (3) COOK INSTINCT ENDOSCOPIC HEMOCLIPS. ACCORDING TO THE END USER: THE FIRST ONE WAS ADVANCED DOWN THE ENDOSCOPE CHANNEL. WHEN OPENING WAS ATTEMPTED, THE CLIP FELL OFF THE DRIVE WIRE (UNKNOWN WHICH POSITION IT WAS IN) [PREMATURE CLIP DEPLOYMENT] (SEE RELATED MDR 1037905-2019-00309). [THE DEVICE WAS] USED IN AN UPPER ENDOSCOPE. THE SECOND DEVICE WAS ADVANCED DOWN THE ENDOSCOPE CHANNEL, AND WHEN THE CLIP CAME OUT THE DISTAL END OF THE ENDOSCOPE CHANNEL THERE WAS NO CLIP. THEY WERE LOOKING AT THE END OF THE CATHETER; PULLED THE CATHETER OUT AND THE CLIP WAS FOUND IN THE "TOILET SEAT" (BIOPSY CAP) [CLIP DETACHED IN ENDOSCOPE] (SEE RELATED MDR 1037905-2019-00310). [THE DEVICE WAS] USED IN AN UPPER ENDOSCOPE. THE THIRD DEVICE WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ENDOSCOPE; THE CUSTOMER GOT IT ALL THE WAY DOWN THE CHANNEL AND IT WAS AT A "TOUGH ANGLE" AND WHEN THEY WENT TO OPEN IT FELL OFF (UNKNOWN IF OPEN OR CLOSED WHEN IT FELL OFF) [PREMATURE CLIP DEPLOYMENT] (SUBJECT OF THIS REPORT). [THE USER] COMPLETED THE PROCEDURES BY USING ADDITIONAL CLIPS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019: THIS O

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

  MAUDE report 8682301 ↗
• MalfunctionJun 7, 2019Premature Activation; Premature Activation

  DURING AN ENDOSCOPIC PROCEDURE THE PHYSICIAN USED THREE (3) COOK INSTINCT ENDOSCOPIC HEMOCLIPS. ACCORDING TO THE END USER: THE FIRST ONE WAS ADVANCED DOWN THE ENDOSCOPE CHANNEL. WHEN OPENING WAS ATTEMPTED, THE CLIP FELL OFF THE DRIVE WIRE (UNKNOWN WHICH POSITION IT WAS IN) [PREMATURE CLIP DEPLOYMENT] (SUBJECT OF THIS REPORT). [THE DEVICE WAS] USED IN AN UPPER ENDOSCOPE. THE SECOND DEVICE WAS ADVANCED DOWN THE ENDOSCOPE CHANNEL, AND WHEN THE CLIP CAME OUT THE DISTAL END OF THE ENDOSCOPE CHANNEL THERE WAS NO CLIP. THEY WERE LOOKING AT THE END OF THE CATHETER; PULLED THE CATHETER OUT AND THE CLIP WAS FOUND IN THE "TOILET SEAT" (BIOPSY CAP) [CLIP DETACHED IN ENDOSCOPE] (SEE RELATED MDR 1037905-2019-00310). [THE DEVICE WAS] USED IN AN UPPER ENDOSCOPE. THE THIRD DEVICE WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ENDOSCOPE; THE CUSTOMER GOT IT ALL THE WAY DOWN THE CHANNEL AND IT WAS AT A "TOUGH ANGLE" AND WHEN THEY WENT TO OPEN IT FELL OFF (UNKNOWN IF OPEN OR CLOSED WHEN IT FELL OFF) [PREMATURE CLIP DEPLOYMENT] (SEE RELATED MDR 1037905-2019-00311). [THE USER] COMPLETED THE PROCEDURES BY USING ADDITIONAL CLIPS. ADDITIONAL INFORMATION RECEIVED ON 17-MAY-2019: THIS O

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

  MAUDE report 8680319 ↗
• MalfunctionJun 7, 2019Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  DURING AN ENDOSCOPIC PROCEDURE THE PHYSICIAN USED THREE (3) COOK INSTINCT ENDOSCOPIC HEMOCLIPS. ACCORDING TO THE END USER: THE FIRST ONE WAS ADVANCED DOWN THE ENDOSCOPE CHANNEL. WHEN OPENING WAS ATTEMPTED, THE CLIP FELL OFF THE DRIVE WIRE (UNKNOWN WHICH POSITION IT WAS IN) [PREMATURE CLIP DEPLOYMENT] (SEE RELATED MDR 1037905-2019-00309). [THE DEVICE WAS] USED IN AN UPPER ENDOSCOPE. THE SECOND DEVICE WAS ADVANCED DOWN THE ENDOSCOPE CHANNEL, AND WHEN THE CLIP CAME OUT THE DISTAL END OF THE ENDOSCOPE CHANNEL THERE WAS NO CLIP. THEY WERE LOOKING AT THE END OF THE CATHETER; PULLED THE CATHETER OUT AND THE CLIP WAS FOUND IN THE "TOILET SEAT" (BIOPSY CAP) [CLIP DETACHED IN ENDOSCOPE] (SUBJECT OF THIS REPORT). [THE DEVICE WAS] USED IN AN UPPER ENDOSCOPE. THE THIRD DEVICE WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ENDOSCOPE; THE CUSTOMER GOT IT ALL THE WAY DOWN THE CHANNEL AND IT WAS AT A "TOUGH ANGLE" AND WHEN THEY WENT TO OPEN IT FELL OFF (UNKNOWN IF OPEN OR CLOSED WHEN IT FELL OFF) [PREMATURE CLIP DEPLOYMENT] (SEE RELATED MDR 1037905-2019-00311). [THE USER] COMPLETED THE PROCEDURES BY USING ADDITIONAL CLIPS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8680315 ↗
• MalfunctionMay 3, 2019Premature Activation; Premature Activation

  DURING A HEMOSTASIS PROCEDURE, THE PHYSICIAN USED AN INSTINCT ENDOSCOPIC HEMOCLIPS. THE CLIP DEPLOYED PREMATURELY INSIDE THE PATIENT. IT IS UNKNOWN IF THE CLIP DEPLOYED IN THE OPEN OR CLOSED POSITION. IT WAS REPORTED THAT THE CLIP DETACHED IN THE PATIENT IN AN UNKNOWN POSITION. HOWEVER, OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

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

  MAUDE report 8579256 ↗
• MalfunctionApr 30, 2019Separation Failure; Separation Failure

  DURING A HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE DEVICE DID NOT DEPLOY PROPERLY. THE DEVICE WAS RECEIVED FOR EVALUATION ON 12-APR-2019 AND THE CLIP WAS NOT INCLUDED WITH THE RETURN. THE FOLLOWING INFORMATION WAS PROVIDED ON (B)(6) 2019 FROM THE CUSTOMER: THIS WAS AN EMERGENCY GASTROINTESTINAL BLEED PATIENT. THE CLIP WOULD NOT DEPLOY. THEY COULD NOT REMEMBER THE POSITION OF THE ENDOSCOPE, SIZE OF CLIPPING SITE OR PATIENT DEMOGRAPHICS. THE REPORTER INDICATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER THE CLIP WAS NOT INCLUDED WITH THE RETURNED DEVICE. 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 8566694 ↗
• MalfunctionApr 4, 2019Premature Activation; Premature Activation

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE CLIP DETACHED IN THE STOMACH, [PREMATURE DEPLOYMENT IN AN UNKNOWN POSITION. THE DEVICE WAS RECEIVED FOR EVALUATION ON 03/19/2019. THE DEPLOYED CLIP WAS NOT RETURNED. THE PREMATURELY DEPLOYED CLIP REMAINED IN THE PATIENT¿S BODY TO PASS NATURALLY. 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; No Consequences Or Impact To Patient

  MAUDE report 8484680 ↗
• MalfunctionMar 19, 2019Premature Activation; Premature Activation

  DURING A HEMOSTASIS PROCEDURE FOR AN ARTERIAL BLEED, THE PHYSICIAN CHOSE THREE (3) INSTINCT ENDOSCOPIC HEMOCLIPS. ONE (1) CLIP FELL OFF OF THE DEVICE [PREMATURELY DEPLOYED IN AN UNKNOWN LOCATION OR POSITION]. THIS OCCURRED EITHER OUTSIDE OF THE PATIENT AND ENDOSCOPE, INSIDE THE ENDOSCOPE, OR IN THE PATIENT. THE POSITION OF THE CLIP, EITHER OPEN OR CLOSED, IS ALSO UNKNOWN. IT HAS NOT BEEN DETERMINED (SUBJECT OF THIS REPORT). TWO (2) CLIPS WERE ULTIMATELY PLACED TO STOP THE BLEED. [THE FOLLOWING DAY] THE PATIENT BEGAN BLEEDING AGAIN AND WENT TO SURGERY (SEE RELATED EMDR 1037905-2019-00141). THE PHYSICIAN DID NOT KNOW IF THE BLEED WAS CAUSED BY THE PREVIOUSLY PLACED CLIPS FALLING OFF [SEPARATING FROM THE SITE PREMATURELY] OR NOT, BUT HE DID SAY THAT THE PATIENT DID NOT HAVE ANY OTHER BLEEDS. IT IS UNKNOWN IF THE CLIP DEPLOYED PRIOR TO PATIENT CONTACT OR DURING PATIENT CONTACT. THE LOCATION OF THE PREMATURELY DEPLOYED CLIP IS UNKNOWN. 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 8434189 ↗
• InjuryMar 19, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING A HEMOSTASIS PROCEDURE FOR AN ARTERIAL BLEED, THE PHYSICIAN CHOSE THREE (3) INSTINCT ENDOSCOPIC HEMOCLIPS. ONE (1) CLIP FELL OFF OF THE DEVICE [PREMATURELY DEPLOYED IN AN UNKNOWN LOCATION OR POSITION]. THIS OCCURRED EITHER OUTSIDE OF THE PATIENT AND ENDOSCOPE, INSIDE THE ENDOSCOPE, OR IN THE PATIENT. THE POSITION OF THE CLIP, EITHER OPEN OR CLOSED, IS ALSO UNKNOWN. IT HAS NOT BEEN DETERMINED (SEE RELATED EMDR 1037905-2019-00140). THE POSITION OF THE CLIP, EITHER OPEN OR CLOSED, IS ALSO UNKNOWN. TWO (2) CLIPS WERE ULTIMATELY PLACED TO STOP THE BLEED. [THE FOLLOWING DAY] THE PATIENT BEGAN BLEEDING AGAIN AND WENT TO SURGERY (SUBJECT OF THIS REPORT). THE PHYSICIAN DID NOT KNOW IF THE BLEED WAS CAUSED BY THE PREVIOUSLY PLACED CLIPS FALLING OFF (SEPARATING FROM THE SITE PREMATURELY) OR NOT, BUT HE DID SAY THAT THE PATIENT DID NOT HAVE ANY OTHER BLEEDS. OTHER THAN THE DEPLOYED CLIPS, A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S BODY. THE PATIENT REQUIRED SURGERY DUE TO BLEEDING FOLLOWING THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, IT IS UNKNOWN IF THIS WAS ATTRIBUTABLE TO CLIP(S) FALLING (OFF THE SITE PREMATURELY); HOWEVER, THE PHYSICIAN STATED THAT THE PATIENT D

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hemostasis

  MAUDE report 8434188 ↗
• MalfunctionFeb 18, 2019Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE CLIP WAS DETACHED FROM THE CATHETER AFTER EXITING THE ENDOSCOPE [CLIP DEPLOYS IN ENDOSCOPE CHANNEL]. THEY WERE ABLE TO RETRIEVE THE CLIP [ELECTIVE REMOVAL]. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER INSTINCT CLIP. 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: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 8348236 ↗
• MalfunctionNov 8, 2018Difficult to Open or Close

  HOMEOSTASIS CLIP WOULD NOT CLOSE ALL THE WAY. THIS WAS NOTED PRIOR TO INSERTING INTO PATIENT. A NEW CLIP WAS OBTAINED AND WAS PLACED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8050421 ↗
• MalfunctionOct 1, 2018Fracture; Fracture

  DURING A CLIPPING PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. AFTER THE CLIP WAS DEPLOYED, THE TIP OF THE HOOK BROKE OFF INTO THE PATIENT. IT WAS LEFT IN THE PATIENT. A SECOND CLIP WAS USED AS ALREADY PLANNED FOR THE PROCEDURE. THE TIP OF THE HOOK REMAINED IN THE PATIENT¿S BODY TO PASS NATURALLY. 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; No Consequences Or Impact To Patient

  MAUDE report 7922173 ↗
• MalfunctionJun 2, 2017Premature Activation; Premature Activation

  DURING AN ENDOSCOPIC CLIPPING PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE FOLLOWING INFORMATION WAS REPORTED TO COOK ON 05/09/2017 VIA THE CUSTOMER'S MEDWATCH (UNKNOWN REFERENCE NUMBER) DATED (B)(6) 2017: "PATIENT WITH GI BLEED TAKEN TO ENDOSCOPY FOR EVALUATION AND CLIP APPLICATION FOR HEMOSTASIS OF ACTIVELY BLEEDING ULCER. COOK ENDOSCOPIC HEMOCLIP DEVICE DID NOT DEPLOY CLIPS PROPERLY. PATIENT TAKEN TO OR FOR OPEN PROCEDURE. EBL [ESTIMATED BLOOD LOSS]: 150 ML. NO INJURY TO PATIENT FROM THE CLIP ITSELF. " THE FOLLOWING INFORMATION WAS INCLUDED IN THE INITIAL EMAIL FROM THE CUSTOMER: "ATTACHED IS A MEDWATCH REPORT REGARDING AN ISSUE WE EXPERIENCED WHILE TRYING TO USE THE INSTINCT HEMOCLIP AT (B)(6). THE CLIP ITSELF DID NOT INJURE THE PATIENT; HOWEVER, SINCE THE CLIP DID NOT WORK AS EXPECTED THE PATIENT HAD TO BE TAKEN TO SURGERY FOR ULCER REPAIR." THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 05/18/2017: "PATIENT HAD TO BE TAKEN TO SURGERY FOR OPEN PROCEDURE [TO REPAIR THE PRE-EXISTING ULCER]. LAPAROTOMY [WAS PERFORMED]. A VERTICAL MIDLINE INCISION WAS MADE FROM THE XIPHOID TO THE UMBILICUS. THE INCISION WAS CARRIED DOWN THROUGH THE FASCIA WITH THE S

  Patient problems: Hemostasis; No Consequences Or Impact To Patient

  MAUDE report 6608461 ↗