BIGopsy G48240Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10827002482408), received between Nov 10, 2021 and Jul 10, 2026 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (29 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Difficult to Open or Close

  Supplemental report is being submitted due to the completion of the investigation on 13-Aug-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25775063 ↗
• MalfunctionNov 24, 2025Difficult to Open or Close; Difficult to Open or Close

  THE RENAL URETER WAS ACCESSED TRANSURETHRALLY USING A URETEROSCOPE, AND A TUMOR IN THE URINARY TRACT WAS BIOPSIED. THE FIRST TISSUE SAMPLE COLLECTION WAS SUCCESSFUL, BUT THE DEVICE MALFUNCTIONED DURING THE SECOND ATTEMPT AND COULD NOT BE USED. THERE WAS NO HEALTH HAZARD AND THE PATIENT WAS RECOVERED. 14NOV2025 OBTAINED FURTHER INFORMATION FROM SALES REP AFTER THE INTERVIEW WITH THE PHYSICIAN. THE BIOPSY CUP, WHICH SHOULD HAVE CLOSED WHEN THE HANDLE ASSEMBLY WAS ATTACHED, DID NOT CLOSE COMPLETELY AND AN INITIAL ATTEMPT AT TISSUE SAMPLING WAS UNSUCCESSFUL. A SENIOR PHYSICIAN WAS HANDED OVER AND ATTEMPTED A SECOND TISSUE SAMPLING, BUT IT DID NOT CLOSE PROPERLY, SO THE TISSUE SAMPLING WAS ABANDONED AND A REPLACEMENT PRODUCT (LOT NO. C2319719) WAS USED TO COMPLETE THE TISSUE SAMPLING. AS A RESULT, TISSUE SAMPLING WAS NOT POSSIBLE EVEN ONCE WITH THE DEFECTIVE PRODUCT. THE PHYSICIANS TESTED BOTH BY GRASPING FILTER PAPER TO COMPARE THEM. THE DEFECTIVE PRODUCT FAILED TO FULLY GRASP THE PAPER, WHILE THE REPLACEMENT PRODUCT HELD IT SECURELY. 14NOV2025 ADDITIONAL INFORMATION WAS OBTAINED. [PHYSICIAN'S COMMENT] SINCE A BIOPSY IS MEANINGLESS IF SUFFICIENT TISSUE CANNOT BE COLLECTED, USING THE DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629758 ↗
• MalfunctionFeb 13, 2025Difficult to Open or Close; Difficult to Open or Close

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE BIOPSY BACKLOADING BIOPSY FORCEPS, G48240, WAS USED. WOLF RIVER ASC HAD 2 BIOPSY FORCEPS THEY COULD NOT GET TO WORK. PER FOLLOW UP WITH DISTRICT MANAGER ON 16-JAN-2025: SPRING ACTION WAS FAULTY. ONE SET DID NOT WANT TO OPEN (B)(4). AND THE OTHER SET DIDN'T WANT TO CLOSE (B)(4). USED A THIRD SET THAT WORKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374816 ↗
• MalfunctionFeb 12, 2025Difficult to Open or Close; Difficult to Open or Close

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 20-JUN-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364908 ↗
• MalfunctionDec 11, 2024Difficult to Open or Close; Difficult to Open or Close

  THE BIOPSY COMES CLOSE. FIRST USE AND THE DOCTOR CONNECTED TO THE HANDLE, BUT IT DID NOT OPEN. NO UNINTENDED SECTION OF THIS DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT UNDERGO PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901488 ↗
• MalfunctionNov 27, 2024Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 29-MAY-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795016 ↗
• MalfunctionAug 28, 2024Difficult to Open or Close; Difficult to Open or Close

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 15-JAN-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086634 ↗
• MalfunctionApr 11, 2024Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent

  THE FORCEPS CUP CANNOT BE OPENED AFTER INSTALLATION. PATIENT/EVENT INFO - NOTES: C5,7,8,10,11 ALL NO.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088259 ↗
• MalfunctionJul 17, 2023Difficult to Open or Close; Difficult to Open or Close

  CUSTOMER EMAILED TO SAY THAT IT WAS IMPOSSIBLE TO DO BIOPSY. THE ITEM WOULDN'T 'ACTIVATE,' IT WOULDN'T OPEN OR CLOSE. THEY HAD TO USE A SECOND PACKET OF SAME ITEM AS THIS ITEM WAS UNUSABLE. "AS PER CC FORM": THE SURGEON OPENED THE PACKAGE, TESTED THE GRASPER BEFORE INTRODUCING IN THE URETEROSCOPE BUT THE GRASPER DIDN'T OPEN. THEY NEEDED TO OPEN ANOTHER PACKAGE TO DO THE BIOPSY. 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 17332951 ↗
• MalfunctionMar 20, 2023Difficult to Open or Close; Difficult to Open or Close

  COMPLAINT RECEIVED FROM DISTRIBUTOR VIA E-MAIL ON 14JUL2021--DID 23JUL2021. AS REPORTED TO CUSTOMER RELATIONS: "THE BIGOPSY DIDN¿T CLOSE PROPERLY, AFTER REASSEMBLING IT SEVERAL TIMES WITHOUT SUCCESS." PATIENT OUTCOME: 1. DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. IF YES, PLEASE DESCRIBE. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. . IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. 6. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. PATIENT/EVENT INFO: NOTES: ADDITIONAL INFORMATION PROVIDED BY CUSTOMER ON 10AUG2021: " WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? NO. IF YES, PLEASE DESCRIBE. R: NO. PLEASE DESCRIBE THE EXACT LOCATION OF THE INT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16572790 ↗
• MalfunctionDec 21, 2022Improper or Incorrect Procedure or Method; Difficult to Open or Close; Improper or Incorrect Procedure or Method; Difficult to Open or Close

  "DEVICE IS A CUP FORCEPS. SOMETHING PROHIBITING THE WIRE FROM GOING ALL THE WAY BACK IN THE WORKING CHANNEL OF THE HAND PIECE. USER COULD STILL OPEN AND CLOSE IT BUT IT WASN'T WORKING THE WAY IT SHOULD BE. USER COULDN'T HEAR A PROPER CLICKING AS EXPECTED. LEFT KIDNEY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023749 ↗
• MalfunctionNov 30, 2022Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent

  THIS FOLLOW UP MDR IS BEING SUBMITTED TO CAPTURE ADDITIONAL INFORMATION RECEIVED ON 01-DEC-2022: THE DEVICE WOULD NOT OPEN OR CLOSE EVEN WHEN THE PROVIDER PUSHED THE WIRE ALL THE WAY BACK INTO THE DEVICE AS HE (THE PROVIDER) USUALLY DOES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15886242 ↗
• MalfunctionOct 28, 2022Difficult to Open or Close; Difficult to Open or Close

  BIOPSY ON RETROGRADE FLEXIBLE URETERO: THE CLAMP DOES NOT ACTIVATE. NO OPENING OR CLOSING. CURRENT PATIENT STATUS: NO CLINICAL CONSEQUENCE: UNABLE TO PERFORM BIOPSY. ACTIONS TAKEN IN THE CARE FACILITY FOR PATIENT MANAGEMENT: OPENING OF A SECOND CLAMP. "AS PER CC FORM": NO PRE EXISTING CONDITION NO CONTACT WITH PATIENT. 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 15690374 ↗
• MalfunctionAug 15, 2022Difficult to Open or Close; Difficult to Open or Close

  THE BIOPSY FORCEPS WOULD NOT BITE AND CUT THE TISSUE, WHEN PULLING BACK ON THE TISSUE WAS NOT ABLE TO PULL THE TISSUE AWAY. A NEW BIGOPSY WAS OPENED AND WORKED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224614 ↗
• MalfunctionAug 12, 2022Difficult to Open or Close; Difficult to Open or Close

  UNSPECIFIED COMPLAINT ON A G48240. FURTHER DETAILS REQUESTED. UPDATED AS PER THE ADDITIONAL INFORMATION RECEIVED FROM THE REP ON (B)(6) 2022: THE BIGOPSY G48240 FAILED TO FUNCTION AND CLOSE CORRECTLY, AND REMAINED STUCK ¿CLOSED¿ EVEN WITH MULTIPLE ATTEMPTS AT CORRECTLY OPERATING THE DEVICE AS PER THE IFU AND INSTRUCTIONS. THE FAULT CAUSED THE NEED FOR ANOTHER OF THE SAME PRODUCT TO BE OPENED WHICH THEN WORKED CORRECTLY FOR THE PROCEDURE. THE LOT OF THE PRODUCT WAS C1823622 EXPIRY 26/4/24. THE PATIENT DIDN¿T REQUIRE ANY FURTHER TREATMENT ONCE THE SECOND PRODUCT WAS OPENED TO COMPLETE THE CASE. FURTHER PATIENT OUTCOME REQUESTED. (B)(6) 2022 UPDATED AS PER EMAIL RECEIVED FROM THE REP ON (B)(6) 2022: NO UNINTENDED PART OF THE DEVICE REMAINED INSIDE THE PATIENT BODY. NO ADVERSE EFFECTS ON THE PATIENT OR THEIR OUTCOMES, JUST A SLIGHTLY LONGER OPERATING PROCEDURE TIME AS A NEW DEVICE WAS NEEDED TO BE OPENED AND USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15215591 ↗
• MalfunctionJun 8, 2022Difficult to Open or Close; Difficult to Open or Close

  BOTH PRODUCTS CAN NOT BE OPENED. "AS PER CC FORM": THE BIOPSY DOES NOT OPEN. LAB EVALUATION COMPLETE ON 01ST JUNE 2022: VISUAL INSPECTION: (362657-1) KINKS OBSERVED ON COIL WIRE AT APPROX 11.5 CM AND 14CM FROM THE END OF THE WIRE. (362657-2) NO VISIBLE KINKS. FUNCTIONAL INSPECTION: (362657-1) WIRE GOES THROUGH AND REMAINS FIXED IN PLACE. JAWS ARE OPENING AND CLOSING WITH RESISTANCE. (362657-2) JAWS OPEN AND CLOSE WITH NO ISSUES . 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. PLEASE DESCRIBE THE EXACT LOCATION OF THE BIOPSY SITE. UPPER POLE, MID POLE, LOWER POLE? NO ANSWER THE BLB DOESN¿T WORK IN ADVANCE. WAS THE PATIENT TAKING ANY ANTICOAGULANTS OR ASPIRIN AT THE TIME OF THE PROCEDURE? N/A, YES, NO N/A. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? THEY FINISH WITH A CUP FORCEPS. WAS THE ANATOMY TORTUOUS? N/A, YES, NO, N/A. WAS THE DEVICE FUNCTIONALITY TESTED PRIOR TO USE? N/A, YES, NO N/A. WHAT TYPE OF SUSPICIOUS TISSUE WAS BEING TARGET FOR THE BIOPSY, I.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14630019 ↗
• MalfunctionJun 3, 2022Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent

  CUSTOMER GOT THE PRODUCT TO WORK ONCE AND A PARTIAL BIOPSY WAS TAKEN FROM THE PATIENT. THE PRODUCT THEN FAILED TO OPEN AND CLOSE AFTER THIS AND PROVED TO BE FAULTY. 3 STAFF MEMBERS AND THE SURGEON ALL TRIED TO GET IT TO WORK, REMOVED THE BIOPSY FORCEPS FROM THE SCOPE, TRIED TO RE ATTACH THEM TO THE HANDLE AND REINSTALL THEM CORRECTLY. THE PRODUCT CONTINUED TO FAIL AND NOT OPERATE NORMALLY. NO UNINTENDED PART OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14587632 ↗
• MalfunctionMay 20, 2022Difficult to Open or Close; Difficult to Open or Close

  CUSTOMER UNHAPPY WITH THE PRODUCT. BIGOPSY BACKLOADING FORCEPS DID NOT PERFORM AS INTENDED. CUSTOMER UNHAPPY WITH THE PRODUCT PERFORMANCE. CUSTOMER STATES BIOPSY SAMPLE COLLECTION WAS SUB PAR, AND EQUIVALENT TO REGULAR CUP BIOPSY AND PRODUCT WAS CLUNKY TO USE, NOT INTUITIVE AND REQUIRED REP SUPPORT OVER THE PHONE TO OPERATE. CUSTOMER OPENED 2 BIOPSY FORCEPS AS THEY THOUGHT THE FIRST ONE WAS MALFUNCTIONING. NO UNINTENDED PART OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461308 ↗
• MalfunctionMar 24, 2022Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent

  BACKLOADING OK BUT THE FORCEPS DID NOT OPEN UP PROPERLY. LAB EVALUATION DATE 11 MAR 2022: VISUAL INSPECTION: KINK OBSERVED APPROX 3.5 CM FROM PROXIMAL TIP OF THE DEVICE. FUNCTIONAL INSPECTION: JAWS WOULD NOT OPEN/CLOSE. 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 13886232 ↗
• MalfunctionFeb 16, 2022Difficult to Open or Close; Difficult to Open or Close

  THAT THIS PRODUCT WAS FAULTY EVEN BEFORE USE. "AS PER CC FORM": THE BIOPSY DIDN¿T WORK BEFORE THE PROCEDURE (OPEN/CLOSE). THERE¿S NO MORE INFORMATION ON THE COMPLAINT THAN; IT COULD NOT OPEN/CLOSE BEFORE USAGE. 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 13542158 ↗
• MalfunctionJan 27, 2022Difficult to Open or Close; Physical Resistance/Sticking; Difficult to Open or Close; Physical Resistance/Sticking

  THERE IS A PROBLEM WITH THE HANDLE, THAT MAKES THAT THE FORCEPS DOESN'T OPEN AND CLOSE PROPERLY. PATIENT OUTCOME: A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NEW PROCEDURE WILL BE PLANNED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. PATIENT/EVENT INFO - NOTES: "PLEASE DESCRIBE THE EXACT LOCATION OF THE BIOPSY SITE. KIDNEY. WAS THE PATIENT TAKING ANY ANTICOAGULANTS OR ASPIRIN AT THE TIME OF THE PROCEDURE? NA. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? NOT. WAS THE ANATOMY TORTUOUS? NO. WAS THE DEVICE FUNCTIONALITY TESTED PRIOR TO USE? YES." FOR OCCURRENCES DURING USE (ONCE IN CONTACT WITH ENDOSCOPE) ALSO ASK: "WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? WAS THE ENDOSCOPE IN A CURVED OR STRAIGHT POSITION? STRAIGHT. DID ANY SECTION OF THE DEVICE DETACH AND BECOME FREE INSIDE THE PATIENT? NO. REP UPDATE 23/09/2021. I DON'T UNDERSTAND THE QUESTIONS AS THIS IS A COMPLAINT REGARDING A BIGOPSY. THERE IS NO WIRE AND THE PROBLEM WAS THE HANDLE. FOLLOWING THE LAB EVALUATION, CAN I PLEAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13366111 ↗
• MalfunctionDec 9, 2021Difficult to Open or Close; Difficult to Open or Close

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967065 ↗
• MalfunctionDec 6, 2021Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER RAN OUT OF STOCK OF BIGOPSY FORCEPS YESTERDAY AND HAD TO BORROW ONE FROM THE CH TO COMPLETE A PROCEDURE. SHE CAME IN THIS MORNING AND WAS TOLD THAT THE BIGOPSY FAILED TO OPEN AND CLOSE THUS NOT WORKING. UPDATED AS PER COMPLAINT FORM RECEIVED ON 27/9/21 JIL01: ACCESS SHEATH WAS IN PLACE AND THE SURGEON BACKLOADED THE DEVICE THROUGH THE FLEXIBLE PYELOSCOPE AS PER IFU AND ATTACHED THE HANDLE AS PER IFU. ONCE THE DEVICE WAS PUT TOGETHER, THE SURGEON TESTED IT PRIOR TO INSERTING IT INTO THE PATIENT VIA THE FLEXOR. IT WAS AT THIS TIME IT WAS NOTED THAT THE CUP WOULD NOT OPEN/CLOSE (PRIOR TO USE INSIDE THE PATIENT). THE ASSEMBLY OF THE DEVICE WAS PERFORMED AGAIN WITH THE SAME OUTCOME. A STONE EXTRACTOR WAS USED TO SNARE A TISSUE SAMPLE INSTEAD AS THEY DID NOT HAVE A SECOND BIGOPSY ON SHELF. NO UNINTENDED PART OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED DUE TO THIS OCCURRENCE. REPLY ON THE REQUESTED ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP ON 21/10/21 JIL01: WAS ANY DAMAGE NOTED TO THE DEVICE PRIOR TO USE? - NO DAMAGE NOTED PRIOR TO USE. WAS THE FORCEPS SHAF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933394 ↗
• MalfunctionDec 6, 2021Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON THE 31-DEC AND DEVICE EVALUATION ON THE 13-DEC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933122 ↗
• MalfunctionDec 6, 2021Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933088 ↗