Captura G56060Recalls & reported problems
Cook Incorporated · Captura Serrated Max Forceps - Spike · Class 2
All models of Captura (37)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002560604), received between May 23, 2017 and Jun 2, 2017 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (4 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 16, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected4
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
DURING COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED MAX FORCEPS-SPIKE. THEY HEARD A SNAPPING SOUND IN THE HANDLE, AND THE FORCEPS WOULD NO LONGER OPEN NOR CLOSE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6608253 ↗MalfunctionMay 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED MAX FORCEPS-SPIKE. DURING INITIAL BIOPSY, THERE WAS A SNAP HEARD IN THE HANDLE OF THE DEVICE AND THE DEVICE WOULD NEITHER OPEN NOR CLOSE AT THAT POINT. ANOTHER ONE WAS OPENED AND USED TO COMPLETE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6591703 ↗MalfunctionMay 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE FOLLOWING WAS REPORTED ON (B)(6) 2017: DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED MAX FORCEPS-SPIKE. ACCORDING TO THE USER, THERE WAS A "MALFUNCTION." THE DEVICE WAS RECEIVED FOR EVALUATION ON (B)(6) 2017. THE CUPS OF THE FORCEPS WOULD OPEN BUT WOULD NOT CLOSE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6585662 ↗MalfunctionMay 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE FOLLOWING WAS REPORTED ON (B)(6) 2017: DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED MAX FORCEPS-SPIKE. ACCORDING TO THE USER, THERE WAS A "MALFUNCTION." THE DEVICE WAS RECEIVED FOR EVALUATION ON 04/28/2017. THE CUPS OF THE FORCEPS WOULD OPEN BUT WOULD NOT CLOSE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6585657 ↗
Other Endoscopic grasping/cutting instrument, non-powered, exempt devices
- Captura G56076Cook Incorporated · Endoscopic grasping/cutting instrument, non-powered, exempt60 reports
- Captura G56133Cook Incorporated · Endoscopic grasping/cutting instrument, non-powered, exempt45 reports
- Single Use Grasping Forceps FG-253SXOlympus Medical Systems Corp. · Endoscopic grasping/cutting instrument, non-powered, exempt27 reports
- Raptor 00711177US Endoscopy · Endoscopic grasping/cutting instrument, non-powered, exempt27 reports
- Captura G31576Cook Incorporated · Endoscopic grasping/cutting instrument, non-powered, exempt19 reports
- Captura G56059Cook Incorporated · Endoscopic grasping/cutting instrument, non-powered, exempt18 reports
- Captura Pro G50697Cook Incorporated · Endoscopic grasping/cutting instrument, non-powered, exempt17 reports
- Captura G31577Cook Incorporated · Endoscopic grasping/cutting instrument, non-powered, exempt17 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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