Captura G53641Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002536418), received between Jun 16, 2017 and May 21, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING BIOPSY PROCEDURES, THE PHYSICIAN USED TWELVE (12) CAPTURA SERRATED LARGE FORCEPS - SPIKE. THE BIOPSY FORCEPS DID NOT CLOSE PROPERLY. WHEN THE PHYSICIAN TRIED TO OPEN THE FORCEPS BEFORE TAKING THE BIOPSY, THE MECHANISM WAS FOUND TO BE BROKE. THEY USED ANOTHER ONE WITHOUT ANY PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7531379 ↗
• MalfunctionMay 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED TWO (2) CAPTURA SERRATED LARGE FORCEPS- SPIKE. THE BIOPSY FORCEPS DID NOT CLOSE PROPERLY. WHEN THE PHYSICIAN TRIED TO OPEN THE FORCEPS BEFORE TAKING THE BIOPSY, THE MECHANISM WAS FOUND TO BE BROKE. THEY USED ANOTHER ONE WITHOUT ANY PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7531233 ↗
• MalfunctionAug 4, 2017Failure to Align; Failure to Align

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP - SPIKE. ON THE THIRD BITE, THE FORCEPS CUPS LOOKED CROOKED. THE TEETH DID NOT LINE UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6766588 ↗
• MalfunctionJun 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEPS - SPIKE. THE FORCEPS SNAPPED WHEN THE NURSE CLOSED THE DEVICE TO TAKE A BIOPSY. THE HANDLE LOST CONTROL OF THE FORCEPS [CUPS]. THE PROCEDURE WAS COMPLETED BY USING ANOTHER FORCEPS WHICH WORKED AS INTENDED. ZERO BIOPSIES WERE TAKEN BEFORE THIS INCIDENT OCCURRED, THIS HAPPENED AS THEY WERE TRYING TO TAKE THEIR FIRST BITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6648469 ↗