Radial Jaw 4 M00513380Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729745648), received between Jun 24, 2021 and Apr 6, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS USED DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING PROCEDURE, METAL PIECES WERE FOUND IN THE CUP. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 BIOPSY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14029776 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS USED DURING A GASTRIC BIOPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE FORCEPS DID NOT CUT PROPERLY AND CAUSED A HEMORRHAGE. FOUR CLIPS WERE PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL OVERNIGHT FOR MONITORING. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE STABLE.

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

  MAUDE report 13598615 ↗
• MalfunctionAug 27, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS TO BE USED FOR A GASTROINTESTINAL BIOPSY PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION, A HAIR-LIKE FOREIGN OBJECT WAS FOUND INSIDE THE STERILE AREA OF THE PACKAGING. NO DAMAGE WAS NOTED IN THE PACKAGING AND IT WAS SEALED. ANOTHER RADIAL JAW 4 BIOPSY FORCEPS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. A PHOTO WAS PROVIDED CONFIRMING THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378456 ↗
• MalfunctionJun 24, 2021Difficult to Open or Close; Appropriate Device Problem Term/Code Not Available; Difficult to Open or Close; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS USED DURING A GASTROINTESTINAL BIOPSY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE FORCEPS FAILED TO CLOSE ON THE THIRD BIOPSY AND COULD NOT BE REMOVED FROM THE SCOPE. THE FORCEPS WERE CUT SO THEY COULD BE REMOVED FROM THE SCOPE. THE PROCEDURE WAS NOT COMPLETED AND THERE IS NO INFORMATION ON WETHER THE PATIENT HAS RESCHEDULED FOR ANOTHER BIOPSY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12062887 ↗