Captura G31583Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002315839), received between Apr 29, 2016 and Dec 2, 2024 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2024Off-Label Use; Off-Label Use

  DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION OF THE ESOPHAGUS [ABNORMAL USE], THE PHYSICIAN USED A COOK CAPTURA HOT BIOPSY FORCEPS. THE LESION WAS SEPARATED BY THERMAL BIOPSY FORCEPS TO STOP BLEEDING, AND THE FRONT END OF THE BIOPSY FORCEPS WAS SUDDENLY BENT AND BROKEN, RESULTING IN THE RUPTURE OF THE BLOOD VESSEL, AND THE MUSCLE OF THE ESOPHAGEAL WALL WHERE THE BLOOD VESSEL WAS LOCATED PENETRATED WOUND. BLEEDING CONTROL [WAS REQUIRED]. USER IMMEDIATELY REPLACE WITH A NEW BIOPSY FORCEPS AND CLIP THE RUPTURED VESSEL TO STOP BLEEDING WITH A TITANIUM CLIP. NO OTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Gastrointestinal Hemorrhage; Laceration(s) of Esophagus

  MAUDE report 20822194 ↗
• MalfunctionFeb 25, 2021Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent

  IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN OPENED THE PACKAGE OF CAPTURA HOT BIOPSY FORCEPS. THE PHYSICIAN DETECTED THE CUPS COULD NOT BE OPENED BEFORE USE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RETURNED FOR INVESTIGATION ON 03 FEBRUARY 2021. THE CUPS WOULD NOT CLOSE WITH HANDLE MANIPULATED ONLY WHEN MANUALLY CLOSING CUPS [SUBJECT OF REPORT]. IN ADDITION, THE INVESTIGATION FOUND EVIDENCE OF POTENTIAL USAGE. THIS WAS ALLEGED TO HAVE OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11381705 ↗
• MalfunctionNov 19, 2020Failure to Align; Failure to Align

  THIS CORRECTION FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SUBMITTED RELATING TO THIS EVENT. REFERENCE THE ADDITIONAL MANUFACTURER NARRATIVE - NOTES SECTION FOR THIS JUSTIFICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10869541 ↗
• MalfunctionDec 6, 2019Fracture; Fracture

  DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA HOT BIOPSY FORCEPS. THE TENSION WIRE [DRIVE WIRE] SNAPPED AND HAD TO BE CUT TO BE REMOVED FROM THE COLONOSCOPE. NOTHING DETACHED IN THE PATIENT OR THE ENDOSCOPE AND THERE WERE NO ADDITIONAL PROCEDURES. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9433459 ↗
• MalfunctionSep 9, 2019Failure to Align; Failure to Align

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA HOT BIOPSY FORCEPS. THE BIOPSY FORCEP BROKE DURING THE PROCEDURE. THE DEVICE WAS REMOVED AND [THE PROCEDURE WAS] COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 15-AUG-2019 AND IT WAS DETERMINED THAT THE CUPS HAVE A GAP IN BETWEEN THE CUPS EDGES. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8976702 ↗
• MalfunctionJun 28, 2019Material Separation; Difficult to Open or Close; Material Separation; Difficult to Open or Close

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK CAPTURA HOT BIOPSY FORCEPS. THE USER OPENED THE PACKAGE AND FOUND OUT THAT THE HANDLE WAS BROKEN. THE USER CHANGED TO ANOTHER OF THE SAME DEVICE TO THE COMPLETE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8744172 ↗
• MalfunctionFeb 1, 2019Difficult to Open or Close; Difficult to Open or Close

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA HOT BIOPSY FORCEPS. THE USER FELT DIFFICULTY USING THE DEVICE HANDLE AND THE FORCEPS CUPS WOULD NOT OPEN AND CLOSE SMOOTHLY. THE USER CHANGED TO ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 07-JAN-2019. DURING A FUNCTION TEST, THE CUPS OPENED, BUT WOULD NOT CLOSE WHEN HANDLE WAS IN USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8297943 ↗
• InjuryJul 17, 2018Off-Label Use; Off-Label Use

  DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), THE PHYSICIAN USED A COOK CAPTURA HOT BIOPSY FORCEPS FOR HEMOSTASIS [ABNORMAL USE]. THE FORCEPS WERE CONNECTED WITH THE ELECTROSURGICAL GENERATOR, BUT THE CURRENT SOURCE WAS ON AND OFF WHICH IS NOT STABLE [INCONSISTENT CURRENT]. THE USER COULD NOT USE THE DEVICE PROPERLY WHICH RESULTED IN EXCESSIVE BURNING OF THE WOUND AND PERFORATION. THE USER USED SEVERAL OF ANOTHER MANUFACTURER'S HEMOSTASIS CLIPS TO STOP THE BLEEDING. FURTHER INFORMATION RECEIVED 13-JULY-2018: THE USER FOLLOWED STANDARD ENDOSCOPIC MUCOSAL DISSECTION (ESD). THEY USED ERBE ELECTROSURGICAL EQUIPMENT TO CUT THE PATIENT¿S EARLY ESOPHAGEAL CANCER (AREA 3-4 MM IN SIZE), WHERE THERE WAS A SLIGHT HEMORRHAGE. THE USER THEN USED THE CLOSED FORCEPS CUPS TO STOP THE BLEEDING. NO BIOPSIES WERE PERFORMED. INTERMITTENT POWER FROM THE FORCEPS WAS NOTICED. PER THE CUSTOMER, THEY COULD NOT BE SURE OF OR CONTROL THE INTERVAL OF STEPPING ON THE ELECTROSURGICAL GENERATOR PEDAL TO PRODUCE CURRENT, BECAUSE THE CURRENT WAS INTERMITTENT. THIS CAUSED EXCESSIVE BURNING AND PERFORATION. THE BLEEDING [NOTED INITIALLY] WAS STOPPED WITH ANOTHER MANUFACTURER¿S HEMOSTASIS CLIPS. THE POWER SETTING

  Patient problems: Perforation

  MAUDE report 7696072 ↗
• MalfunctionJun 22, 2018Material Separation; Material Separation

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA HOT BIOPSY FORCEPS. THE USER COMPLETED HEMOSTASIS AND TRIED TO RETRACT THE DEVICE FROM BIOPSY CHANNEL OF ENDOSCOPE, BUT MET RESISTANCE. THE USER WITHDREW THE ENDOSCOPE ALONG WITH THE FORCEPS IN IT FROM PATIENT, AND PULLED THE DEVICE FROM THE ENDOSCOPE BIOPSY CHANNEL AFTERWARD [AFTER THE ENDOSCOPE WAS OUTSIDE OF THE PATIENT]. THE USER FOUND THAT THE FORCEPS ARE LOOSE FROM CATHETER. THE PHOTO PROVIDED SHOWS THE INNER CABLE OF THE HOT FORCEPS EXPOSED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7629601 ↗
• MalfunctionAug 18, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED TWO (2) COOK CAPTURA HOT BIOPSY FORCEPS. [THE FORCEPS] WOULD NOT OPEN OR CLOSE DURING PREPARATION.

  Patient problems: No Patient Involvement

  MAUDE report 6803718 ↗
• MalfunctionFeb 3, 2017Failure to Align; Failure to Align

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED TWO (2) COOK CAPTURA HOT BIOPSY FORCEPS. [THE PHYSICIAN] INSERTED THE FORCEPS INTO ACCESSORY CHANNEL OF ENDOSCOPE, BUT THE PHYSICIAN FOUND THE CUP COULD NOT CLOSE SYMMETRICALLY [CUPS ARE MISALIGNED DURING USE]. THE SAME PROBLEM WAS FOUND ON THE SECOND DEVICE. THE PROCEDURE WAS FINISHED SUCCESSFULLY BY CHANGING TO THE THIRD SAME TYPE OF DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6301072 ↗
• MalfunctionDec 16, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA HOT BIOPSY FORCEPS. POTENTIAL CUP MISALIGNMENT WAS OBSERVED DURING THE DEVICE EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6182882 ↗
• MalfunctionApr 29, 2016Failure to Align; Failure to Align

  THIS CORRECTION FOLLOW UP REPORT IS BEING SENT TO CANCEL THE INITIAL REPORT SUBMITTED RELATING TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5619404 ↗