Captura G53642Recalls & reported problems
Cook Incorporated · Captura Serrated Jumbo Forcep - No Spike · Class 2
All models of Captura (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002536425), received between Jul 31, 2017 and Jul 31, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected2
- Failure to Align1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2017Failure to Align; Device Operates Differently Than Expected; Failure to Align; Device Operates Differently Than Expected
THE FOLLOWING WAS REPORTED ON (B)(6) 2017: DURING AN ENDOSCOPIC BIOPSY PROCEDURE, THE PHYSICIAN USED TWO (2) CAPTURA SERRATED JUMBO FORCEPS NO SPIKE. THE CUSTOMER COMPLAINED THAT THE FORCEPS HEAD IS DEVIATED. THE PRODUCTS CANNOT BE USED. THE FOLLOWING WAS RECEIVED VIA THE COMPLAINT FORM ON 07/09/2017: AFTER OPENING, THE BRANCHES [FORCEPS CUPS] WOULD NOT CLOSE ANYMORE. THE DEVICES WERE EVALUATED ON 07/24/2017. ONE (1) OF THE DEVICES WAS FOUND TO BE POTENTIALLY MISALIGNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6753576 ↗MalfunctionJul 31, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE FOLLOWING WAS REPORTED ON (B)(6) 2017: THE CUSTOMER COMPLAINS THAT THE FORCEPS HEAD IS DEVIATED. THE PRODUCTS CANNOT BE USED. THE FOLLOWING WAS RECEIVED VIA THE COMPLAINT FORM ON (B)(6) 2017: AFTER OPENING, THE BRANCHES [CUPS] WOULD NOT CLOSE ANYMORE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6753428 ↗
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 G31577Cook Incorporated · Endoscopic grasping/cutting instrument, non-powered, exempt17 reports
- Captura Pro G50697Cook 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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