DISPOSABLE BIOPSY FORCEPS FB-210U (REF N5355330)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170354113), received between Oct 16, 2019 and Aug 10, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING UNSPECIFIED DIAGNOSTIC PROCEDURES, THE DISPOSABLE BIOPSY FORCEPS WAS TAKING BIG "BITES" OUT OF THE MUCOSA, CAUSING BLEEDING. THE PHYSICIAN WAS UNCOMFORTABLE WITH THE LARGE SAMPLE. SOME OF THE PATIENTS REQUIRED HEMOSTATIC METHODS SUCH AS CAUTERY OR CLIPS. THE PROCEDURES WERE NOT DELAYED DUE TO THE ISSUE AND THE OUTCOME OF THE PROCEDURE WAS UNAFFECTED. THIS EVENT REQUIRES TWO REPORTS. PATIENT IDENTIFIER (B)(6) IS FOR AN INDIVIDUAL PATIENT. PATIENT IDENTIFIER (B)(6) IS FOR "SOME PATIENT'S" OF UNKNOWN QUANTITY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 17499527 ↗
• InjuryAug 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING UNSPECIFIED DIAGNOSTIC PROCEDURES, THE DISPOSABLE BIOPSY FORCEPS WAS TAKING BIG "BITES" OUT OF THE MUCOSA, CAUSING BLEEDING. THE PHYSICIAN WAS UNCOMFORTABLE WITH THE LARGE SAMPLE. SOME OF THE PATIENTS REQUIRED HEMOSTATIC METHODS SUCH AS CAUTERY OR CLIPS. THE PROCEDURES WERE NOT DELAYED DUE TO THE ISSUE AND THE OUTCOME OF THE PROCEDURE WAS UNAFFECTED. THIS EVENT REQUIRES TWO REPORTS. PATIENT IDENTIFIER (B)(6) IS FOR AN INDIVIDUAL PATIENT. PATIENT IDENTIFIER (B)(6) IS FOR "SOME PATIENT'S" OF UNKNOWN QUANTITY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 17499315 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING UNSPECIFIED DIAGNOSTIC PROCEDURES, THE DISPOSABLE BIOPSY FORCEPS WAS TAKING BIG "BITES" OUT OF THE MUCOSA, CAUSING BLEEDING. THE PHYSICIAN WAS UNCOMFORTABLE WITH THE LARGE SAMPLE. SOME OF THE PATIENTS REQUIRED HEMOSTATIC METHODS SUCH AS CAUTERY OR CLIPS. THE PROCEDURES WERE NOT DELAYED DUE TO THE ISSUE AND THE OUTCOME OF THE PROCEDURE WAS UNAFFECTED. THIS EVENT REQUIRES TWO REPORTS. PATIENT IDENTIFIER (B)(6) IS FOR AN INDIVIDUAL PATIENT. PATIENT IDENTIFIER (B)(6) IS FOR "SOME PATIENT'S" OF UNKNOWN QUANTITY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 17498664 ↗
• InjuryAug 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A USER FACILITY REPORTED TO OLYMPUS THAT DURING UNSPECIFIED DIAGNOSTIC PROCEDURES, THE DISPOSABLE BIOPSY FORCEPS WAS TAKING BIG "BITES" OUT OF THE MUCOSA, CAUSING BLEEDING. THE PHYSICIAN WAS UNCOMFORTABLE WITH THE LARGE SAMPLE. SOME OF THE PATIENTS REQUIRED HEMOSTATIC METHODS SUCH AS CAUTERY OR CLIPS. THE PROCEDURES WERE NOT DELAYED DUE TO THE ISSUE AND THE OUTCOME OF THE PROCEDURE WAS UNAFFECTED. THIS EVENT REQUIRES TWO REPORTS. PATIENT IDENTIFIER (B)(6) IS FOR AN INDIVIDUAL PATIENT. PATIENT IDENTIFIER (B)(6) IS FOR "SOME PATIENT'S" OF UNKNOWN QUANTITY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 17498586 ↗
• InjuryOct 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ENDOSCOPY PROCEDURE, THE FORCEPS DID NOT COME OUT OF THE SHEATH PROPERLY. CUSTOMER CONFIRMED THAT THE EVENT CAUSED A LARGE TEAR IN ¿ESOPHAGUS¿ THAT REQUIRED A CLIP CLOSURE. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO OTHER DEVICE REPLACED DURING THE PROCEDURE AND THE SUBJECT DEVICE WAS NOT RETURNING AS IT WAS DISCARDED BY THE CUSTOMER AFTER USE.

  Patient problems: Laceration(s)

  MAUDE report 9199342 ↗