Captura Pro G47692Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002476929), received between Apr 18, 2019 and Nov 15, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Fracture; Nonstandard Device; Detachment of Device or Device Component; Fracture; Nonstandard Device; Detachment of Device or Device Component

  DURING AN UNKNOWN PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT PART OF THE PRODUCT BROKE OFF [THE FORCEPS JAW BROKE OFF] OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED. ADDITIONAL ATTEMPTS TO GATHER THIS INFORMATION WILL BE MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695713 ↗
• MalfunctionApr 10, 2024Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device; Detachment of Device or Device Component

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS INITIALLY REPORTED THAT IT WAS BROKEN RIGHT OUT OF THE PACKAGE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RETURNED FOR EVALUATION AND RECEIVED ON 20MAR2024 AND THE CUP HAD DETACHED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19081617 ↗
• MalfunctionNov 15, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE PHYSICIAN HAD TAKEN A BIOPSY. AFTER TAKING THE SPECIMEN OUT OF THE FORCEPS, THEY NOTICED ONE OF THE CUPS HAD COME OFF. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18142077 ↗
• MalfunctionSep 16, 2020Difficult to Open or Close; Component Misassembled; Difficult to Open or Close; Component Misassembled

  PRIOR TO A COLONOSCOPY PROCEDURE, THE PHYSICIAN PREPARED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. WHEN THE CUSTOMER OPENED THE PACKAGE AND PRE-TESTED THE DEVICE, IT HAD TO BE FORCED OPEN AND WOULD NOT CLOSE AFTER THAT. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10541166 ↗
• MalfunctionNov 22, 2019Difficult to Open or Close; Difficult to Open or Close

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. ONE OF THE JAWS ON THE FORCEPS WOULD NOT CLOSE ALL THE WAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 9364122 ↗
• MalfunctionSep 12, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. THE FORCEPS WERE DEFECTIVE. PER THE COOK AREA REPRESENTATIVE, THERE IS NO FURTHER INFORMATION AVAILABLE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 21-AUG-2019 AND THE FORCEP CUPS WERE FOUND TO BE POTENTIALLY MISALIGNED. OUR ATTEMPT TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9012489 ↗
• MalfunctionAug 30, 2019Failure to Align; Failure to Align

  IN PREPARATION FOR A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. THE DEVICE WAS TESTED BEFORE USE AND THE BIOPSY CUPS WOULD NOT OPEN UP ALL THE WAY. A NEW FORCEPS DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THIS DEVICE WAS RECEIVED FOR EVALUATION ON 06-AUG-2019 AND THE CUPS APPEAR TO BE MISALIGNED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8951920 ↗
• MalfunctionJun 24, 2019Fracture; Fracture

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. THEY WENT DOWN [THE ENDOSCOPE WITH THE DEVICE]. THEY TRIED TO BIOPSY THE SIDE OF THE STOMACH WALL. THEN, THE FORCEPS BENT. THEY COULD NOT GET IT BACK THROUGH THE ENDOSCOPE THROUGH THE CHANNEL. THEY HAD TO PULL THE ENDOSCOPE OUT WITH THE DEVICE. THEY THEN HAD TO CUT THE TIP OF THE FORCEPS OFF TO GET IT TO EXIT THE ACCESSORY PORT ON THE ENDOSCOPE." THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 30-MAY-2019: THERE WAS A DRIVE WIRE MISSING. ADDITIONAL INFORMATION WAS RECEIVED ON 04-JUNE-2019: THE CUSTOMER STATED NOTHING WAS LEFT IN THE PATIENT. FROM THE PHOTO IT IS INCONCLUSIVE IF ANYTHING IS MISSING. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. A PORTION OF THE DRIVE WIRE IS MISSING, HOWEVER THE LOCATION IS UNKNOWN. 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 8729277 ↗
• MalfunctionApr 18, 2019Difficult to Open or Close; Difficult to Open or Close

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. AFTER THE FIRST BIOPSY, THE FORCEPS WOULD NOT CLOSE ALL THE WAY AND ONE SIDE OF THE JAW [CUPS] WAS STUCK OPEN. A NEW SAME DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. 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 8527819 ↗