Radial Jaw 4 M00513450Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729745709), received between Jun 7, 2019 and Sep 7, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 - PEDIATRIC - BIOPSY FORCEPS WAS USED IN THE PLEURAL SPACE DURING A BIOPSY PROCEDURE ON (B)(6), 2023. DURING THE PROCEDURE, THE PULL WIRE BROKE, AND A FRAGMENT FELL INTO THE PATIENT'S PLEURAL SPACE. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED, AND A CT CHEST SCAN SHOWED NO ISSUES. ANOTHER RADIAL JAW WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703011 ↗
• InjuryAug 4, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW FORCEPS WAS USED IN THE URETER DURING A THORACOSCOPY WITH PLEURAL BIOPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PULL WIRE BECAME DISLODGED INSIDE THE PATIENT. WHILE ONE PIECE WAS SUCCESSFULLY RETRIEVED, THE OTHER PIECE COULD NOT BE LOCATED. THE PLEURAL SPACE WAS COMPLETELY SUCTIONED, BUT IT REMAINS UNCERTAIN IF THE MISSING PIECE WAS RETRIEVED WITH THE FLUID. ANOTHER RADIAL JAW FORCEPS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17458275 ↗
• InjuryJun 7, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PEDIATRIC BIOPSY FORCEPS WAS USED IN THE LUNG DURING A TRANSBRONCHIAL BIOPSY PROCEDURE RELATED TO A RIGHT MIDDLE LOBE CAVITARY LESION PERFORMED ON (B)(6) 2019. DURING THE PROCEDURE, A MONARCH ROBOTIC BRONCHOSCOPE WAS INSERTED INTO THE RIGHT MIDDLE LOBE OF THE LUNGS. ONCE THE BRONCHOSCOPE REACHED THE TARGET, PHYSICIAN FIRST USED A NON-BSC NEEDLE TO ACQUIRE A SAMPLE OF THE NODULE. AFTER A FEW UNSUCCESSFUL ATTEMPTS, A NON-BSC FORCEPS WAS THEN USED TO ATTEMPT TO ACQUIRE A SAMPLE BUT WAS STILL UNSUCCESSFUL. THE FORCEPS WAS THEN REPLACED WITH THE RADIAL JAW 4 PEDIATRIC BIOPSY FORCEPS. ACCORDING TO THE PHYSICIAN, "I HAD TAKEN SOMEWHERE BETWEEN 8 AND 10 BIOPSIES AND LITERALLY WAS ON MY LAST BIOPSY. I EXTENDED THE FORCEPS INTO THE MIDDLE LOBE, THE TECHNICIAN OPENED THE FORCEPS AND UNDER FLUOROSCOPY WE WERE READY TO TAKE THE LAST BIOPSY. WHEN I ASKED HER TO CLOSE THE FORCEPS AND THEN TRIED TO TAKE MY BIOPSY I COULD NOT RETRACT THE FORCEPS. FLUOROSCOPY REVEALED THE JAWS TO BE OPEN. I ASKED THE TECHNICIAN TO CLOSE THE JAWS AND THEY WOULD NOT CLOSE. I THEN ASKED HER TO OPEN THE JAWS AND AT THAT MOMENT WITH MY HAND ON THE CATHE

  Patient problems: No Code Available

  MAUDE report 8680474 ↗