Captura Pro G47693Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002476936), received between Feb 12, 2019 and Feb 7, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE, G47693. IT WAS REPORTED THAT WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING IT WAS NOTED TO BE BENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE PATIENT SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333647 ↗
• MalfunctionNov 4, 2024Difficult to Open or Close; Difficult to Open or Close

  DURING AN UNKNOWN PROCEDURE, THE PHYSICIAN USED A CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT ONE OF THE DRIVE CABLES BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. 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 20605039 ↗
• MalfunctionOct 3, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close

  DURING AN UPPER ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THEY MADE MULTIPLE SUCCESSFUL BIOPSIES WITH THIS DEVICE AND THEN LATER IN THE CASE, THE ARM BROKE ON ONE OF THE CUPS. IT IS BARELY ATTACHED TO THE DEVICE. THEY HAD CUT TO CUT THE TIP OFF OF THE DEVICE IN ORDER TO REMOVE IT FROM THE SCOPE. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER DEVICE OF THE SAME TYPE. 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 20359104 ↗
• MalfunctionAug 12, 2024Fracture; Nonstandard Device; Detachment of Device or Device Component; Fracture; Nonstandard Device; Detachment of Device or Device Component

  DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT WHEN THEY WERE TAKING A BIOPSY, ONE OF THE CUPS/JAWS OF THE BIOPSY FORCEPS FELL OFF. THEY WERE ABLE RETRIEVE IT BECAUSE THE CUP WAS SUCTIONED UP AND WAS STUCK TO THE TIP OF THE SCOPE AT THE OPENING OF THE BIOPSY PORT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION AS THIS WAS THE LAST BITE TO REMOVE THE POLYP. 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 19967438 ↗
• MalfunctionSep 8, 2023Difficult to Open or Close; Difficult to Open or Close

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE DEFECTIVE END WAS STUCK OPEN INSIDE SCOPE. THE FORCEPS WERE INSERTED INTO EGD SCOPE TO OBTAIN ESOPHAGEAL BIOPSIES, THEN OPENED. WHEN INSTRUCTED TO CLOSE THE MD & NURSE NOTICED THAT THE FORCEPS WOULD NOT CLOSE, PART OF THE BITE [CUP/JAW LINK WIRE] HAD BROKEN OFF [DISCONNECTED FROM CATHETER]. 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 17711090 ↗
• MalfunctionJun 22, 2023Difficult to Open or Close; Difficult to Open or Close

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE HANDLE BROKE DURING THE PROCEDURE. THERE WAS A LOUD CRACK FROM THE HANDLE. THE FORCEP WOULD NOT CLOSE PROPERLY. THE FORCEP HAS TO BE OPENED AND CLOSED SEVERAL TIMES TO GET THEM TO CLOSE PROPERLY. A NEW FORCEP WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 05/30/2023 AND IT WAS NOTED THAT THE CUPS WERE IN THE OPEN POSITION (STUCK OPEN) AND WOULD NOT CLOSE FULLY WHEN THE HANDLE WAS MANIPULATED [SUBJECT OF REPORT]. 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 17181290 ↗
• InjuryMay 9, 2023Fracture; Difficult to Open or Close; Component Misassembled; Fracture; Difficult to Open or Close; Component Misassembled

  A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A COLONOSCOPY PROCEDURE IN WHICH THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE FORCEPS WERE ADVANCED THROUGH A FUJINON SCOPE AND WHEN ATTEMPTED TO OPEN THE JAWS OF THE FORCEPS ONE OF THE JAWS BROKE OFF INSIDE THE PATIENT. THE DEVICE WAS REMOVED AND THE JAW PIECE RETRIEVED WITH A PAIR OF FORCEPS. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. CLARIFICATION OF THE EVENT HAS BEEN REQUESTED AS THE DEVICE WAS RECEIVED FOR EVALUATION AND NO PARTS OR COMPONENTS WERE MISSING OR SEPARATED FROM THE DEVICE RECEIVED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16896921 ↗
• MalfunctionMar 6, 2023Break; Detachment of Device or Device Component; Difficult to Open or Close; Break; Detachment of Device or Device Component; Difficult to Open or Close

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE METAL "JAW" [CUP] PART WITH THE SERRATED EDGES FELL APART. 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 16487036 ↗
• MalfunctionSep 27, 2022Break; Fracture; Difficult to Open or Close; Break; Fracture; Difficult to Open or Close

  A PATIENT OF UNSPECIFIED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE NURSE HEARD A 'CLICKING' SOUND WHEN OPENING AND CLOSING THE FORCEPS. THE NURSE STATED THAT DEVICE HAS DUAL CORDS [WIRES] AND ONE OF THEM BROKE. ANOTHER OF THE SAME DEVICE WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15490885 ↗
• MalfunctionAug 13, 2021Difficult to Open or Close; Difficult to Open or Close

  DURING AN UPPER ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE TIP OF THE FORCEPS WAS BENT. THEY [PHYSICIAN] WAS ABLE TO OPEN IT TO TAKE A BITE BUT WHEN THEY TRIED TO CLOSE ONTO THE TISSUE, THEY WERE NOT ABLE TO CLOSE THE JAW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. 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 12320871 ↗
• InjuryAug 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. THE FORCEPS WERE ADVANCED DOWN THROUGH THE ENDOSCOPE AND WHEN THE STAFF PERSONNEL WENT TO OPEN THE FORCEPS, THEY BROKE. THE JAW CLAMP [FORCEPS CUPS] CAME OFF. ANOTHER FORCEPS WAS USED TO RETRIEVE JAW CLAMPS. NO HARM TO THE PATIENT. THEY USED ANOTHER FORCEPS TO COMPLETE THE PROCEDURE. THE DEVICE WAS EVALUATED AND THE ENTIRE CUPS HOUSING AND TWO LINK WIRES WERE RETURNED DETACHED FROM THE COIL CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE DETACHED PORTION OF THE FORCEPS WAS RETRIEVED WITH ANOTHER FORCEPS DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 8866788 ↗
• MalfunctionFeb 12, 2019Difficult to Open or Close; Difficult to Open or Close

  DURING AN UPPER ENDOSCOPY BIOPSY, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. AFTER THE PROCEDURE WAS COMPLETE, THE TECHNICIAN NOTED THAT THE CUP WAS COMING LOOSE [TROMBONING] FROM THE CATHETER. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS FUNCTIONALLY TESTED ON 18-JAN-2019: THE CUPS OPENED AND CLOSED AS DESIGNED WHEN THE HANDLE WAS MANIPULATED. THE SPIKE WAS NOT STRAIGHT, AND DURING FUNCTION TESTING THE SPIKE MOVED TO THE SIDE AND CAUSED THE CUPS NOT TO CLOSE FULLY. 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 8333149 ↗