Radial Jaw 4 M00513300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729745488), received between Dec 14, 2017 and Jul 8, 2025 — 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.

• MalfunctionJul 8, 2025Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4, JUMBO AND LARGE CAPACITY FORCEPS WAS USED DURING AN OESOPHAGO-GASTRO DUODENOSCOPY (OGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE RADIAL JAW 4 BIOPSY FORCEPS BECAME LODGED WITHIN THE ENDOSCOPE. THE SCOPE, ALONG WITH THE FORCEPS, WAS WITHDRAWN AND SENT TO THE DECONTAMINATION UNIT. THE BIOPSY SPECIMEN REMAINED INSIDE THE SCOPE AND WAS NOT RETRIEVED. THE SAMPLE WAS DEEMED TO BE OF NO CLINICAL SIGNIFICANCE AND THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436315 ↗
• MalfunctionMar 6, 2023Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW WAS USED DURING A STOMACH BIOPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, A RADIAL JAW HAD SHARP MATERIAL AT THE TIP OF THE TWEEZERS, WHICH COULD CAUSE MUCOSAL LACERATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16484381 ↗
• MalfunctionSep 14, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS A HAIR INSIDE THE PRIMARY PACKAGE, AND STERILITY OF THE DEVICE WAS COMPROMISED. REPORTEDLY, THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7879412 ↗
• InjuryDec 14, 2017Adverse 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 LARGE CAPACITY BIOPSY FORCEPS WAS USED DURING A BIOPSY PROCEDURE PERFORMED BETWEEN (B)(6), 2017 AND (B)(6), 2017. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED BLEEDING AFTER THE PROCEDURE AND WAS HOSPITALIZED. THE PATIENT¿S HEMOGLOBIN LEVEL DROPPED FROM 14 TO 9. ADDITIONALLY, IT WAS REPORTED THAT THERE WERE NO ISSUES NOTED ON THE DEVICE AT THE TIME OF PROCEDURE. REPORTEDLY, THE PATIENT¿S CONDITION IS STABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7118057 ↗