DISPOSABLE BIOPSY FORCEPS FB-220U (REF N5355430)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 04953170354120), received between Oct 24, 2018 and Aug 8, 2024 — classified as 8 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (19 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED DURING A DIAGNOSTIC GASTROSCOPY PROCEDURE THE DISPOSABLE BIOPSY FORCEPS DID NOT CUT PROPERLY WHEN SAMPLING THE GASTRIC MUCOSA. THE ISSUE RESULTED IN A LACERATION OF THE MUCOSA CAUSING BLEEDING AND REQUIRING A CLIP. THE PROCEDURE TIME WAS EXTENDED FOR 15 MINUTES DUE TO THE EVENT. THERE WAS NO FURTHER PATIENT IMPACT REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 19937905 ↗
• MalfunctionFeb 5, 2020Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  THE SERVICE CENTER RECEIVED A REPORT OF SEVEN SEPARATE DISPOSABLE BIOPSY FORCEPS (MODEL FB-220U), LOT NUMBER 97V, THAT DID NOT PERFORM AS EXPECTED, NOT CUTTING WELL DURING PROCEDURES. THIS IS FOR THE SEVENTH SET OF BIOPSY FORCEPS THAT DID NOT CUT WELL FOR A PHYSICIAN DURING AN UNSPECIFIED PROCEDURE. THE BIOPSY FORCEPS WERE INSPECTED UPON OPENING OF THE PACKAGE AND NO ABNORMALITIES WERE OBSERVED. THE PHYSICIAN PROCEEDED WITH THE INTENDED PROCEDURE AND IT WAS REPORTED THE DEVICE DID TEAR TISSUE. IT WAS REPORTED THERE WAS NO BLOOD LOSS. THE DEVICE WAS DISPOSED OF AT THE SUCCESSFUL COMPLETION OF THE SURGERY. IT WAS REPORTED THERE WAS NO PATIENT DEATH OR INJURY AND THE PATIENT WAS DISCHARGED TO HOME AS NORMAL. THIS IS REPORT 7 OF 7.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673702 ↗
• MalfunctionFeb 5, 2020Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  THE SERVICE CENTER RECEIVED A REPORT OF SEVEN SEPARATE DISPOSABLE BIOPSY FORCEPS (MODEL FB-220U), LOT NUMBER 97V, THAT DID NOT PERFORM AS EXPECTED, NOT CUTTING WELL DURING PROCEDURES. THIS IS FOR THE SIXTH SET OF BIOPSY FORCEPS THAT DID NOT CUT WELL FOR A PHYSICIAN DURING AN UNSPECIFIED PROCEDURE. THE BIOPSY FORCEPS WERE INSPECTED UPON OPENING OF THE PACKAGE AND NO ABNORMALITIES WERE OBSERVED. THE PHYSICIAN PROCEEDED WITH THE INTENDED PROCEDURE AND IT WAS REPORTED THE DEVICE DID TEAR TISSUE. IT WAS REPORTED THERE WAS NO BLOOD LOSS. THE DEVICE WAS DISPOSED OF AT THE SUCCESSFUL COMPLETION OF THE SURGERY. IT WAS REPORTED THERE WAS NO PATIENT DEATH OR INJURY AND THE PATIENT WAS DISCHARGED TO HOME AS NORMAL. THIS IS REPORT 6 OF 7.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673695 ↗
• MalfunctionFeb 5, 2020Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  THE SERVICE CENTER RECEIVED A REPORT OF SEVEN SEPARATE DISPOSABLE BIOPSY FORCEPS (MODEL FB-220U), LOT NUMBER 97V, THAT DID NOT PERFORM AS EXPECTED, NOT CUTTING WELL DURING PROCEDURES. THIS IS FOR THE FIFTH SET OF BIOPSY FORCEPS THAT DID NOT CUT WELL FOR A PHYSICIAN DURING AN UNSPECIFIED PROCEDURE. THE BIOPSY FORCEPS WERE INSPECTED UPON OPENING OF THE PACKAGE AND NO ABNORMALITIES WERE OBSERVED. THE PHYSICIAN PROCEEDED WITH THE INTENDED PROCEDURE AND IT WAS REPORTED THE DEVICE DID TEAR TISSUE. IT WAS REPORTED THERE WAS NO BLOOD LOSS. THE DEVICE WAS DISPOSED OF AT THE SUCCESSFUL COMPLETION OF THE SURGERY. IT WAS REPORTED THERE WAS NO PATIENT DEATH OR INJURY AND THE PATIENT WAS DISCHARGED TO HOME AS NORMAL. THIS IS REPORT 5 OF 7.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673680 ↗
• MalfunctionFeb 5, 2020Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  THE SERVICE CENTER RECEIVED A REPORT OF SEVEN SEPARATE DISPOSABLE BIOPSY FORCEPS (MODEL FB-220U), LOT NUMBER 97V, THAT DID NOT PERFORM AS EXPECTED, NOT CUTTING WELL DURING PROCEDURES. THIS IS FOR THE FOURTH SET OF BIOPSY FORCEPS THAT DID NOT CUT WELL FOR A PHYSICIAN DURING AN UNSPECIFIED PROCEDURE. THE BIOPSY FORCEPS WERE INSPECTED UPON OPENING OF THE PACKAGE AND NO ABNORMALITIES WERE OBSERVED. THE PHYSICIAN PROCEEDED WITH THE INTENDED PROCEDURE AND IT WAS REPORTED THE DEVICE DID TEAR TISSUE. IT WAS REPORTED THERE WAS NO BLOOD LOSS. THE DEVICE WAS DISPOSED OF AT THE SUCCESSFUL COMPLETION OF THE SURGERY. IT WAS REPORTED THERE WAS NO PATIENT DEATH OR INJURY AND THE PATIENT WAS DISCHARGED TO HOME AS NORMAL. THIS IS REPORT 4 OF 7.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673669 ↗
• MalfunctionFeb 5, 2020Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  THE SERVICE CENTER RECEIVED A REPORT OF SEVEN SEPARATE DISPOSABLE BIOPSY FORCEPS (MODEL FB-220U), LOT NUMBER 97V, THAT DID NOT PERFORM AS EXPECTED, NOT CUTTING WELL DURING PROCEDURES. THIS IS FOR THE THIRD SET OF BIOPSY FORCEPS THAT DID NOT CUT WELL FOR A PHYSICIAN DURING AN UNSPECIFIED PROCEDURE. THE BIOPSY FORCEPS WERE INSPECTED UPON OPENING OF THE PACKAGE AND NO ABNORMALITIES WERE OBSERVED. THE PHYSICIAN PROCEEDED WITH THE INTENDED PROCEDURE AND IT WAS REPORTED THE DEVICE DID TEAR TISSUE. IT WAS REPORTED THERE WAS NO BLOOD LOSS. THE DEVICE WAS DISPOSED OF AT THE SUCCESSFUL COMPLETION OF THE SURGERY. IT WAS REPORTED THERE WAS NO PATIENT DEATH OR INJURY AND THE PATIENT WAS DISCHARGED TO HOME AS NORMAL. THIS IS REPORT 3 OF 7.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673661 ↗
• MalfunctionFeb 5, 2020Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  THE SERVICE CENTER RECEIVED A REPORT OF SEVEN SEPARATE DISPOSABLE BIOPSY FORCEPS (MODEL FB-220U), LOT NUMBER 97V, THAT DID NOT PERFORM AS EXPECTED, NOT CUTTING WELL DURING PROCEDURES. THIS IS FOR THE SECOND SET OF BIOPSY FORCEPS THAT DID NOT CUT WELL FOR A PHYSICIAN DURING AN UNSPECIFIED PROCEDURE. THE BIOPSY FORCEPS WERE INSPECTED UPON OPENING OF THE PACKAGE AND NO ABNORMALITIES WERE OBSERVED. THE PHYSICIAN PROCEEDED WITH THE INTENDED PROCEDURE AND IT WAS REPORTED THE DEVICE DID TEAR TISSUE. IT WAS REPORTED THERE WAS NO BLOOD LOSS. THE DEVICE WAS DISPOSED OF AT THE SUCCESSFUL COMPLETION OF THE SURGERY. IT WAS REPORTED THERE WAS NO PATIENT DEATH OR INJURY AND THE PATIENT WAS DISCHARGED TO HOME AS NORMAL. THIS IS REPORT 2 OF 7.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673648 ↗
• MalfunctionFeb 5, 2020Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  THE SERVICE CENTER RECEIVED A REPORT OF SEVEN SEPARATE DISPOSABLE BIOPSY FORCEPS (MODEL FB-220U), LOT NUMBER 97V, THAT DID NOT PERFORM AS EXPECTED, NOT CUTTING WELL DURING PROCEDURES. THIS IS FOR THE FIRST SET OF BIOPSY FORCEPS THAT DID NOT CUT WELL FOR A PHYSICIAN DURING AN UNSPECIFIED PROCEDURE. THE BIOPSY FORCEPS WERE INSPECTED UPON OPENING OF THE PACKAGE AND NO ABNORMALITIES WERE OBSERVED. THE PHYSICIAN PROCEEDED WITH THE INTENDED PROCEDURE AND IT WAS REPORTED THE DEVICE DID TEAR TISSUE. IT WAS REPORTED THERE WAS NO BLOOD LOSS. THE DEVICE WAS DISPOSED OF AT THE SUCCESSFUL COMPLETION OF THE SURGERY. IT WAS REPORTED THERE WAS NO PATIENT DEATH OR INJURY AND THE PATIENT WAS DISCHARGED TO HOME AS NORMAL. THIS IS REPORT 1 OF 7.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673625 ↗
• MalfunctionJan 22, 2020Dull, Blunt; Dull, Blunt

  THE SERVICE CENTER RECEIVED A REPORT OF FOUR DISPOSABLE BIOPSY FORCEPS, MODEL FB-220U, ALL FROM THE SAME LOT NUMBER 97V, THAT WERE REPORTED TO HAVE DULL TEETH ON THE JAWS AND THAT DID NOT CUT. THIS IS FOR THE FOURTH SET OF DISPOSABLE FORCEPS THAT DID NOT CUT AS REPORTED BUT TORE TISSUE DURING THE PROCEDURE. IT WAS REPORTED THE FORCEPS WERE INSPECTED PRIOR TO THE PROCEDURE AND NO ANOMALIES WERE OBSERVED. A PHYSICIAN WAS PERFORMING A COLONOSCOPY WHEN IT WAS REPORTED THE FOURTH SET OF FORCEPS USED, TORE TISSUE. IT WAS REPORTED THE FORCEPS WAS ACTING ABNORMALLY PRIOR TO TEARING THE TISSUE BUT THE ACTUAL DESCRIPTION (I.E. ABNORMAL BEHAVIOR) WAS NOT PROVIDED. IT WAS ALSO INDICATED IT IS NOT KNOWN WHICH SPECIFIC SET OF FORCEPS TORE TISSUE OR IF ALL CAUSED TEARS DURING THE PROCEDURE. THE PROVIDED INFORMATION INDICATED THE PATIENT DID NOT INCUR ANY BLOOD LOSS, AND THE DEVICE WAS USED TO COMPLETE THE INTENDED PROCEDURE. THE PATIENT WAS DISCHARGED AS NORMAL WITH NO REPORTED INJURY. THE FOLLOWING DEVICES WERE USED CONCOMITANTLY DURING THE PROCEDURE: OLYMPUS CV, CLV 190 AND PCF190. THIS IS REPORT 4 OF 4.

  Patient problems: Excessive Tear Production; No Known Impact Or Consequence To Patient

  MAUDE report 9616052 ↗
• MalfunctionJan 22, 2020Dull, Blunt; Dull, Blunt

  THE SERVICE CENTER RECEIVED A REPORT OF FOUR DISPOSABLE BIOPSY FORCEPS, MODEL FB-220U, ALL FROM THE SAME LOT NUMBER 97V, THAT WERE REPORTED TO HAVE DULL TEETH ON THE JAWS AND THAT DID NOT CUT. THIS IS FOR THE THIRD SET OF DISPOSABLE FORCEPS THAT DID NOT CUT AS REPORTED BUT TORE TISSUE DURING THE PROCEDURE. IT WAS REPORTED THE FORCEPS WERE INSPECTED PRIOR TO THE PROCEDURE AND NO ANOMALIES WERE OBSERVED. A PHYSICIAN WAS PERFORMING A COLONOSCOPY WHEN IT WAS REPORTED THE THIRD SET OF FORCEPS USED, TORE TISSUE. IT WAS REPORTED THE FORCEPS WAS ACTING ABNORMALLY PRIOR TO TEARING THE TISSUE BUT THE ACTUAL DESCRIPTION (I.E. ABNORMAL BEHAVIOR) WAS NOT PROVIDED. IT WAS ALSO INDICATED IT IS NOT KNOWN WHICH SPECIFIC SET OF FORCEPS TORE TISSUE OR IF ALL CAUSED TEARS DURING THE PROCEDURE. THE PROVIDED INFORMATION INDICATED THE PATIENT DID NOT INCUR ANY BLOOD LOSS, AND A NEW DEVICE WAS USED TO CONTINUE WITH THE INTENDED PROCEDURE. THE PATIENT WAS DISCHARGED AS NORMAL WITH NO REPORTED INJURY. THE FOLLOWING DEVICES WERE USED CONCOMITANTLY DURING THE PROCEDURE: OLYMPUS CV, CLV 190 AND PCF190. THIS IS REPORT 3 OF 4.

  Patient problems: Excessive Tear Production; No Known Impact Or Consequence To Patient

  MAUDE report 9616040 ↗
• MalfunctionJan 22, 2020Dull, Blunt; Dull, Blunt

  THE SERVICE CENTER RECEIVED A REPORT OF FOUR DISPOSABLE BIOPSY FORCEPS, MODEL FB-220U, ALL FROM THE SAME LOT NUMBER 97V, THAT WERE REPORTED TO HAVE DULL TEETH ON THE JAWS AND THAT DID NOT CUT. THIS IS FOR THE SECOND SET OF DISPOSABLE FORCEPS THAT DID NOT CUT AS REPORTED BUT TORE TISSUE DURING THE PROCEDURE. IT WAS REPORTED THE FORCEPS WERE INSPECTED PRIOR TO THE PROCEDURE AND NO ANOMALIES WERE OBSERVED. A PHYSICIAN WAS PERFORMING A COLONOSCOPY WHEN IT WAS REPORTED THE SECOND SET OF FORCEPS USED, TORE TISSUE. IT WAS REPORTED THE FORCEPS WAS ACTING ABNORMALLY PRIOR TO TEARING THE TISSUE BUT THE ACTUAL DESCRIPTION (I.E. ABNORMAL BEHAVIOR) WAS NOT PROVIDED. IT WAS ALSO INDICATED IT IS NOT KNOWN WHICH SPECIFIC SET OF FORCEPS TORE TISSUE OR IF ALL CAUSED TEARS DURING THE PROCEDURE. THE PROVIDED INFORMATION INDICATED THE PATIENT DID NOT INCUR ANY BLOOD LOSS, AND A NEW DEVICE WAS USED TO CONTINUE WITH THE INTENDED PROCEDURE. THE PATIENT WAS DISCHARGED AS NORMAL WITH NO REPORTED INJURY. THE FOLLOWING DEVICES WERE USED CONCOMITANTLY DURING THE PROCEDURE: OLYMPUS CV, CLV 190 AND PCF190. THIS IS REPORT 2 OF 4.

  Patient problems: Excessive Tear Production; No Known Impact Or Consequence To Patient

  MAUDE report 9616016 ↗
• MalfunctionJan 21, 2020Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  ELEVEN FACILITY PHYSICIANS STATE WHILE USING THE FB-220U, THE CUT IS NOT AS SMOOTH AS EXPECTED. IT WAS CUTTING BUT IT FELT MORE LIKE A TEAR THAN A SMOOTH CUT. THERE WAS NO PATIENT INJURY OR DEATH DUE TO THIS ISSUE. NO PATIENT INFORMATION PROVIDED. IT WAS REPORTED THAT NO UNCONTROLLED BLEEDING OCCURRED, NO INJURIES OR NO MEDICAL INTERVENTION WAS NECESSARY. THE PROCEDURES WHERE THE DEVICE WAS USED WERE ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY. PROCEDURES WERE COMPLETED WITH THE SAME BIOPSY FORCEPS. PHYSICIANS ARE EXPERIENCED USING THE DEVICE. REPORT 9 OF 11.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9613111 ↗
• MalfunctionJan 21, 2020Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  ELEVEN FACILITY PHYSICIANS STATE WHILE USING THE FB-220U, THE CUT IS NOT AS SMOOTH AS EXPECTED. IT WAS CUTTING BUT IT FELT MORE LIKE A TEAR THAN A SMOOTH CUT. THERE WAS NO PATIENT INJURY OR DEATH DUE TO THIS ISSUE. NO PATIENT INFORMATION PROVIDED. IT WAS REPORTED THAT NO UNCONTROLLED BLEEDING OCCURRED, NO INJURIES OR NO MEDICAL INTERVENTION WAS NECESSARY. THE PROCEDURES WHERE THE DEVICE WAS USED WERE ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY. PROCEDURES WERE COMPLETED WITH THE SAME BIOPSY FORCEPS. PHYSICIANS ARE EXPERIENCED USING THE DEVICE. REPORT 9 OF 11.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9612650 ↗
• MalfunctionJan 21, 2020Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  ELEVEN FACILITY PHYSICIANS STATE WHILE USING THE FB-220U, THE CUT IS NOT AS SMOOTH AS EXPECTED. IT WAS CUTTING BUT IT FELT MORE LIKE A TEAR THAN A SMOOTH CUT. THERE WAS NO PATIENT INJURY OR DEATH DUE TO THIS ISSUE. NO PATIENT INFORMATION PROVIDED. IT WAS REPORTED THAT NO UNCONTROLLED BLEEDING OCCURRED, NO INJURIES OR NO MEDICAL INTERVENTION WAS NECESSARY. THE PROCEDURES WHERE THE DEVICE WAS USED WERE ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY. PROCEDURES WERE COMPLETED WITH THE SAME BIOPSY FORCEPS. PHYSICIANS ARE EXPERIENCED USING THE DEVICE. REPORT 8 OF 11.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9612636 ↗
• MalfunctionJan 21, 2020Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  ELEVEN FACILITY PHYSICIANS STATE WHILE USING THE FB-220U, THE CUT IS NOT AS SMOOTH AS EXPECTED. IT WAS CUTTING BUT IT FELT MORE LIKE A TEAR THAN A SMOOTH CUT. THERE WAS NO PATIENT INJURY OR DEATH DUE TO THIS ISSUE. NO PATIENT INFORMATION PROVIDED. IT WAS REPORTED THAT NO UNCONTROLLED BLEEDING OCCURRED, NO INJURIES OR NO MEDICAL INTERVENTION WAS NECESSARY. THE PROCEDURES WHERE THE DEVICE WAS USED WERE ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY. PROCEDURES WERE COMPLETED WITH THE SAME BIOPSY FORCEPS. PHYSICIANS ARE EXPERIENCED USING THE DEVICE. REPORT 10 OF 11.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9612629 ↗
• MalfunctionJan 21, 2020Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  ELEVEN FACILITY PHYSICIANS STATE WHILE USING THE FB-220U, THE CUT IS NOT AS SMOOTH AS EXPECTED. IT WAS CUTTING BUT IT FELT MORE LIKE A TEAR THAN A SMOOTH CUT. THERE WAS NO PATIENT INJURY OR DEATH DUE TO THIS ISSUE. NO PATIENT INFORMATION PROVIDED. IT WAS REPORTED THAT NO UNCONTROLLED BLEEDING OCCURRED, NO INJURIES OR NO MEDICAL INTERVENTION WAS NECESSARY. THE PROCEDURES WHERE THE DEVICE WAS USED WERE ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY. PROCEDURES WERE COMPLETED WITH THE SAME BIOPSY FORCEPS. PHYSICIANS ARE EXPERIENCED USING THE DEVICE. REPORT 7 OF 11.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9612600 ↗
• MalfunctionJan 21, 2020Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  ELEVEN FACILITY PHYSICIANS STATE WHILE USING THE FB-220U, THE CUT IS NOT AS SMOOTH AS EXPECTED. IT WAS CUTTING BUT IT FELT MORE LIKE A TEAR THAN A SMOOTH CUT. THERE WAS NO PATIENT INJURY OR DEATH DUE TO THIS ISSUE. NO PATIENT INFORMATION PROVIDED. IT WAS REPORTED THAT NO UNCONTROLLED BLEEDING OCCURRED, NO INJURIES OR NO MEDICAL INTERVENTION WAS NECESSARY. THE PROCEDURES WHERE THE DEVICE WAS USED WERE ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY. PROCEDURES WERE COMPLETED WITH THE SAME BIOPSY FORCEPS. PHYSICIANS ARE EXPERIENCED USING THE DEVICE. REPORT 6 OF 11.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9612579 ↗
• MalfunctionJan 21, 2020Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  ELEVEN FACILITY PHYSICIANS STATE WHILE USING THE FB-220U, THE CUT IS NOT AS SMOOTH AS EXPECTED. IT WAS CUTTING BUT IT FELT MORE LIKE A TEAR THAN A SMOOTH CUT. THERE WAS NO PATIENT INJURY OR DEATH DUE TO THIS ISSUE. NO PATIENT INFORMATION PROVIDED. IT WAS REPORTED THAT NO UNCONTROLLED BLEEDING OCCURRED, NO INJURIES OR NO MEDICAL INTERVENTION WAS NECESSARY. THE PROCEDURES WHERE THE DEVICE WAS USED WERE ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY. PROCEDURES WERE COMPLETED WITH THE SAME BIOPSY FORCEPS. PHYSICIANS ARE EXPERIENCED USING THE DEVICE. REPORT 5 OF 11.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9612393 ↗
• MalfunctionJan 21, 2020Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  ELEVEN FACILITY PHYSICIANS STATE WHILE USING THE FB-220U, THE CUT IS NOT AS SMOOTH AS EXPECTED. IT WAS CUTTING BUT IT FELT MORE LIKE A TEAR THAN A SMOOTH CUT. THERE WAS NO PATIENT INJURY OR DEATH DUE TO THIS ISSUE. NO PATIENT INFORMATION PROVIDED. IT WAS REPORTED THAT NO UNCONTROLLED BLEEDING OCCURRED, NO INJURIES OR NO MEDICAL INTERVENTION WAS NECESSARY. THE PROCEDURES WHERE THE DEVICE WAS USED WERE ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY. PROCEDURES WERE COMPLETED WITH THE SAME BIOPSY FORCEPS. PHYSICIANS ARE EXPERIENCED USING THE DEVICE. REPORT 4 OF 11.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9612377 ↗
• MalfunctionJan 21, 2020Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  ELEVEN FACILITY PHYSICIANS STATE WHILE USING THE FB-220U, THE CUT IS NOT AS SMOOTH AS EXPECTED. IT WAS CUTTING BUT IT FELT MORE LIKE A TEAR THAN A SMOOTH CUT. THERE WAS NO PATIENT INJURY OR DEATH DUE TO THIS ISSUE. NO PATIENT INFORMATION PROVIDED. IT WAS REPORTED THAT NO UNCONTROLLED BLEEDING OCCURRED, NO INJURIES OR NO MEDICAL INTERVENTION WAS NECESSARY. THE PROCEDURES WHERE THE DEVICE WAS USED WERE ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY. PROCEDURES WERE COMPLETED WITH THE SAME BIOPSY FORCEPS. PHYSICIANS ARE EXPERIENCED USING THE DEVICE. REPORT 3 OF 11.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9612371 ↗
• MalfunctionJan 21, 2020Dull, Blunt; Dull, Blunt

  THE SERVICE CENTER RECEIVED A REPORT OF FOUR DISPOSABLE BIOPSY FORCEPS, MODEL FB-220U, ALL FROM THE SAME LOT NUMBER 97V, THAT WERE REPORTED TO HAVE DULL TEETH ON THE JAWS AND THAT DID NOT CUT. THIS IS FOR THE FIRST SET OF DISPOSABLE FORCEPS THAT DID NOT CUT AS REPORTED BUT TORE TISSUE DURING THE PROCEDURE. IT WAS REPORTED THE FORCEPS WERE INSPECTED PRIOR TO THE PROCEDURE AND NO ANOMALIES WERE OBSERVED. A PHYSICIAN WAS PERFORMING A COLONOSCOPY WHEN IT WAS REPORTED THE FIRST SET OF FORCEPS USED, TORE TISSUE. IT WAS REPORTED THE FORCEPS WAS ACTING ABNORMALLY PRIOR TO TEARING THE TISSUE BUT THE ACTUAL DESCRIPTION (I.E. ABNORMAL BEHAVIOR) WAS NOTED PROVIDED. THE PROVIDED INFORMATION INDICATED THE PATIENT DID NOT INCUR ANY BLOOD LOSS AND A NEW DEVICE WAS USED TO CONTINUE WITH THE INTENDED PROCEDURE. THE PATIENT WAS DISCHARGED AS NORMAL WITH NO REPORTED INJURY. THE FOLLOWING DEVICES WERE USED CONCOMITANTLY DURING THE PROCEDURE: OLYMPUS CV, CLV 190 AND PCF190. THIS IS REPORT 1 OF 4.

  Patient problems: Excessive Tear Production; No Known Impact Or Consequence To Patient

  MAUDE report 9612324 ↗
• MalfunctionJan 21, 2020Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  ELEVEN FACILITY PHYSICIANS STATE WHILE USING THE FB-220U, THE CUT IS NOT AS SMOOTH AS EXPECTED. IT WAS CUTTING BUT IT FELT MORE LIKE A TEAR THAN A SMOOTH CUT. THERE WAS NO PATIENT INJURY OR DEATH DUE TO THIS ISSUE. NO PATIENT INFORMATION PROVIDED. IT WAS REPORTED THAT NO UNCONTROLLED BLEEDING OCCURRED, NO INJURIES OR NO MEDICAL INTERVENTION WAS NECESSARY. THE PROCEDURES WHERE THE DEVICE WAS USED WERE ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY. PROCEDURES WERE COMPLETED WITH THE SAME BIOPSY FORCEPS. PHYSICIANS ARE EXPERIENCED USING THE DEVICE. REPORT 2 OF 11.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9612236 ↗
• MalfunctionJan 21, 2020Mechanical Problem; Failure to Cut; Mechanical Problem; Failure to Cut

  ELEVEN FACILITY PHYSICIANS STATE WHILE USING THE FB-220U, THE CUT IS NOT AS SMOOTH AS EXPECTED. IT WAS CUTTING BUT IT FELT MORE LIKE A TEAR THAN A SMOOTH CUT. THERE WAS NO PATIENT INJURY OR DEATH DUE TO THIS ISSUE. NO PATIENT INFORMATION PROVIDED. IT WAS REPORTED THAT NO UNCONTROLLED BLEEDING OCCURRED, NO INJURIES OR NO MEDICAL INTERVENTION WAS NECESSARY. THE PROCEDURES WHERE THE DEVICE WAS USED WERE ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY. PROCEDURES WERE COMPLETED WITH THE SAME BIOPSY FORCEPS. PHYSICIANS ARE EXPERIENCED USING THE DEVICE. REPORT 1 OF 11.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9612233 ↗
• MalfunctionDec 9, 2019Material Split, Cut or Torn

  THE PROCEDURE BEING PERFORMED WAS ESOPHAGOGASTRODUODENOSCOPY AND COLONOSCOPY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9439280 ↗
• InjuryJul 12, 2019Adverse Event Without Identified Device or Use Problem

  THE SERVICE CENTER WAS INFORMED THAT DURING A DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, WHILE OBTAINING A BIOPSY THE PATIENT EXPERIENCED A LOT OF BLEEDING AND DEVELOPED A HEMATOMA. THE BLEEDING WAS TREATED WITH TWO CLIPS. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. (REFER TO REPORT 1 OF 2). ADDITIONALLY, THE USER FACILITY REPORTED THAT THIS PHENOMENON HAS OCCURRED WITH MULTIPLE PHYSICIANS. THIS IS REPORT 2 OF 2.

  Patient problems: Blood Loss; Hematoma

  MAUDE report 8785721 ↗