Radial Jaw 4 M00513320Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729745525), received between Oct 5, 2017 and Nov 23, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 30, 2026Class IIOpen, Classified

   Potential for breach in sterile barrier of device packaging.

   Z-2839-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2020Adverse 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 BIOPSY FORCEPS WAS USED IN A DISSECTION AND REMOVAL OF INTRA-GASTRIC LAP BAND PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A RADIAL JAW WAS USED TO GRASP THE JAGWIRE. HOWEVER, THE ANESTHETIST NOTICED THE PATIENT HEMORRHAGING FROM THE MOUTH WHEN THE GUIDEWIRE WAS IN POSITION AND THE DOCTOR WAS THREADING THE MECHANICAL LITHOTRIPSY SHEATH ON THE WIRE. THE DOCTOR HAD THE GASTROSCOPE IN THE ESOPHAGUS AWAITING FOR THE LITHOCRUSH TO ARRIVE. THE PATIENT WAS UNDER GENERAL ANESTHETIC. THE PLANNED PROCEDURE WAS HALTED; EMERGENCY ENT (EAR, NOSE, AND THROAT) AND GI (GASTROINTESTINAL) SURGICAL CONSULTATIONS OCCURRED, EMERGENCY BLEEDING AND WOUND MANAGEMENT (MOUTH/BASE OF TONGUE) WAS CARRIED OUT. THE PLANNED PROCEDURE WAS COMPLETED FOLLOWING WHICH THE PATIENT WAS ADMITTED TO ICU (INTENSIVE CARE UNIT) UNDER SEDATION. PATIENT OBESITY WITH A LARGE TONGUE WAS REPORTED AS ONE OF THE CO-MORBIDITIES THAT POSSIBLY LEAD TO THE EVENT. REPORTEDLY, IN THE PHYSICIAN'S ASSESSMENT IN PART THE DEVICE MALFUNCTION OF THE JAGWIRE CONTRIBUTED TO HEMORRHAGING FROM THE MOUTH. THE PROCEDURE WAS COMPLETED WITH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10889123 ↗
• InjuryAug 13, 2019Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Human-Device Interface 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 THAT WAS USED FOR A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BOWEL WAS TORN WHEN TAKING A BIOPSY IN THE RIGHT COLON. THREE ENDOCLIPS WERE USED TO CLOSE THE DEFECT. THE COMPLAINANT NOTED THAT THE DEVICE WAS NOT LABELED CLEARLY. 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: Perforation

  MAUDE report 8888500 ↗
• MalfunctionOct 5, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HAIR WAS NOTED INSIDE THE UNOPENED PACKAGE OF A RADIAL JAW¿ 4 BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW¿ 4 BIOPSY FORCEPS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6916001 ↗