Captura G53042Recalls & reported problems
Cook Incorporated · Captura Serrated Jumbo Forceps - 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 00827002530423), received between Jun 22, 2017 and Jul 21, 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
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 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
DURING TWO (2) SEPARATE COLONOSCOPY PROCEDURES, THE PHYSICIAN USED ONE (1) COOK CAPTURA SERRATED JUMBO FORCEPS- SPIKE IN EACH PROCEDURE. AS REPORTED TO COOK CUSTOMER RELATIONS BY THE SALES REPRESENTATIVE: "I AM HAVING SOME TROUBLE WITH THE JUMBO CAPTURA FORCEPS. I HAVE HAD TWO BREAK WHILE WE WERE TRYING TO USE THEM. IT CAUSED US TO HAVE TO PULL THE COLONOSCOPE AND FORCEPS OUT AT THE SAME TIME. I PULLED ALL OF THIS LOT NUMBER. [THERE WERE] TWO (2) DIFFERENT PROVIDERS AND TWO (2) DIFFERENT TECHNICIANS [INVOLVED IN THE PROCEDURES]."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6733585 ↗MalfunctionJun 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED JUMBO FORCEPS-SPIKE. THEY TOOK A BITE. DURING THE BITE, THEY HEARD A SNAP AND THEN THE DEVICE WOULD NO LONGER OPEN OR CLOSE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6661666 ↗
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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