Instinct G58010Recalls & reported problems
Cook Incorporated · Instinct Plus Endoscopic Clipping Device · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Cook Instinct Plus endoscopic clipping device is a metal clip tool used in the digestive tract to stop bleeding. The 1,000 reports often describe clips that would not fire or deploy, material separating, and the device being hard to open or close. There are 25 injury reports and no deaths. Reports fell from 295 in the prior 12 months to 130 in the last 12. 1 recall is open, begun in March 2026, over rising complaints that the device could malfunction.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,017
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,017 adverse event reports that list this exact device (DI 00827002580107), received between Apr 29, 2021 and Sep 30, 2026 — classified as 26 injuries, 991 malfunctions.
The most frequently reported specific device problem is “Material Separation” (522 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Mar 3, 2026Open, Classified
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
Z-1812-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Material Separation522
- Difficult to Open or Close506
- Failure to Fire251
- Premature Separation204
- Separation Failure191
- Improper or Incorrect Procedure or Method90
- Difficult or Delayed Separation37
- Nonstandard Device7
Patient problems
- No Clinical Signs, Symptoms or Conditions961
- Gastrointestinal Hemorrhage31
- Foreign Body In Patient15
- Insufficient Information8
- Laceration(s)3
- Failure of Implant2
- Perforation2
Recent adverse event reports
The 25 most recent of 1,017 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Fire
During endoscopic procedure to clip on ulcer, the physician used a Cook Instinct Plus Endoscopic Clipping Device. It was reported that the clip would not release from the catheter but was able to reopen from tissue.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 50947275 ↗MalfunctionSep 30, 2026Failure to Fire
During an endoscopic clipping procedure, the physician used two Cook Instinct Plus Endoscopic Clipping Devices. It was reported that the clips failed to deploy and were able to be reopened from tissue.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 50946848 ↗MalfunctionSep 30, 2026Failure to Fire
During clipping in the sigmoid post polyp removal, the physician used a Cook Instinct Plus Endoscopic Clipping Device. It was reported that the clip closed perfectly but once "[the user]" crunched, the clip did not deploy, (heard the deployment) but the clip was still on the catheter.Another clip was used and deployed perfect as it should.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 50946716 ↗MalfunctionSep 28, 2026Activation, Positioning or Separation Problem
Clip would not deploy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913184 ↗MalfunctionSep 25, 2026Separation Failure; Failure to Fire
During clipping to stop bleeding post polypectomy in the colon, the physician used a Cook Instinct Plus Endoscopic Clipping Device. It was reported that the forceps "[jaws]" open and close, but the clip does not release, despite attempts to reposition the clip and the forceps "[jaws]", and efforts by the surgeon and nursing staff.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 50898572 ↗MalfunctionSep 25, 2026Failure to Fire
During an endoscopic clipping procedure, the physician used multiple Cook Instinct Plus Endoscopic Clipping Devices. It was initially reported that the clip was not opening. There was no reportable information at that time. Additional information received on 28 Aug 2026 indicated that the clip was unable to deploy but able to open from tissue "[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 50896370 ↗MalfunctionSep 24, 2026Failure to Fire
During an endoscopic clipping procedure, the physician used a Cook Instinct Plus Endoscopic Clipping Device. It was reported that the clip did not deploy but could be reopened. Another clip was used to finish 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 50886245 ↗MalfunctionSep 24, 2026Material Separation; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884335 ↗MalfunctionSep 24, 2026Separation Failure; Failure to Fire
During an endoscopic clipping procedure, the physician used a Cook Instinct Plus Endoscopic Clipping Device. It was reported that while the clip was being inserted through the scope, the staff member was holding the red part of the handle, the clip could not 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. 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 50883693 ↗MalfunctionSep 22, 2026Failure to Fire
During an endoscopic clipping procedure, the physician used two Cook Instinct Plus Endoscopic Clipping Devices. It was reported that the clips did not deploy. They get on tissue and they will not fire but they were able to reopen the clips to remove them from tissue. Another clip was grabbed 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 50852526 ↗MalfunctionSep 21, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50844970 ↗MalfunctionSep 21, 2026Failure to Fire
During an endoscopic clipping procedure, the physician used two Cook Instinct Plus Endoscopic Clipping Devices. It was reported that the clips did not deploy. They get on tissue and they will not fire but they were able to reopen the clips to remove them from tissue. Another clip was grabbed 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 50842532 ↗MalfunctionSep 21, 2026Failure to Fire
During a gastroscopy, the physician used a Cook Instinct Plus Endoscopic Clipping Device. It was reported that the clip was not able to deploy when activated and it still didn't work when out of scope.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 50842421 ↗MalfunctionSep 21, 2026Separation Failure; Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841989 ↗MalfunctionSep 19, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832569 ↗MalfunctionSep 19, 2026Separation Failure; Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832560 ↗MalfunctionSep 18, 2026Separation Failure; Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828050 ↗MalfunctionSep 17, 2026Material Separation; Difficult to Open or Close
During a colonoscopy, the physician used a Cook Instinct Plus Endoscopic Clipping Device. It was reported that when going to deploy the clip, it tromboned "[clip housing detached from the catheter attachment and remained attached to the drive wire]". They were able to remove the clip and used another clip to finish 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 50802757 ↗MalfunctionSep 17, 2026Activation Failure
Cook clip would not deploy. Everlift turned mucosa white and would not bubble.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801787 ↗MalfunctionSep 16, 2026Material Separation; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794531 ↗MalfunctionSep 16, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790928 ↗MalfunctionSep 16, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50787978 ↗MalfunctionSep 16, 2026Failure to Fire
During an endoscopic clipping procedure, the physician used a Cook Instinct Plus Endoscopic Clipping Device. It was reported that the user was able to open and close clip on the mucosa, but it would not deploy.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 50787887 ↗MalfunctionSep 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763545 ↗MalfunctionSep 14, 2026Material Separation; Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763325 ↗
Other Hemostatic metal clip for the GI tract devices
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- Instinct G18343Cook Incorporated · Hemostatic metal clip for the GI tract244 reports
- MANTIS™ Clip M00521420Boston Scientific Corporation · Hemostatic metal clip for the GI tract195 reports
- Single Use Repositionable Clip HX-202UROlympus Medical Systems Corp. · Hemostatic metal clip for the GI tract1 recall118 reports
- colonic FTRD Set 14Ovesco Endoscopy AG · Hemostatic Metal Clip For The Gi Tract2 deaths95 reports
- Single Use Repositionable Clip HX-202UROlympus Medical Systems Corp. · Hemostatic metal clip for the GI tract87 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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