Captura G54170Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002541702), received between Oct 26, 2017 and May 15, 2018 — 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2018Failure to Align; Device Operates Differently Than Expected; Failure to Align; Device Operates Differently Than Expected

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED MAX FORCEPS-SPIKE. ONE BRANCH [CUP] COULD NOT BE OPENED. NO MAXIMUM TENSION OR OPENING WAS POSSIBLE. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS EVALUATED ON 04/20/2018. THE CUPS WOULD OPEN AND CLOSE, HOWEVER UPON THE CUPS CLOSING, THE TEETH WOULD NOT COME TOGETHER FULLY. WHEN APPLYING EXCESSIVE PRESSURE TO THE HANDLE THE FORCEPS, THE TEETH WOULD COME CLOSE TOGETHER, BUT NEVER CLOSE FULLY. THE FORCEPS CUPS WAS VISUALLY INSPECTED USING MAGNIFICATION AND THE CUPS EXHIBIT A SMALL GAP BETWEEN THE TEETH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7516153 ↗
• MalfunctionOct 26, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, A PHYSICIAN USED A CAPTURA SERRATED MAX FORCEPS - SPIKE. THE USER WAS IN THE TRANSVERSE COLON. A POLYPECTOMY WAS ATTEMPTED TO BE PERFORMED. THE FORCEPS WAS OPENED TO GRAB THE POLYP, BUT THE FORCEPS WOULD NOT CLOSE. THE COMPLAINT DEVICE WAS REMOVED AND A NEW CAPTURA SERRATED MAX FORCEPS- SPIKE WAS OPENED AND USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6979150 ↗