Radial Jaw 4 M00513330Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729745549), received between Jun 7, 2016 and Jan 30, 2026 — classified as 6 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 30, 2026Open, Classified

   Potential for breach in sterile barrier of device packaging.

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

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026

  RADIAL JAW/BIOPSY FORCEPS PLACED DOWN SCOPE, NOT NOTED UNTIL PRESENTATION AT END OF SCOPE A SLIVER OF METAL PROTRUDING FROM FORCEPS GRASPER, IMMEDIATELY REMOVED AND NEW FORCEPS USED WITHOUT FURTHER INCIDENT DURING CASE OR HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220591 ↗
• MalfunctionDec 8, 2025Break

  DEVICE BROKE BEFORE ENTERING THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735984 ↗
• MalfunctionOct 22, 2025Difficult to Open or Close; Physical Resistance/Sticking

  FROM STAFF: FORCEPS NOT FULLY OPENING STUCK CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356515 ↗
• MalfunctionAug 19, 2025Mechanical Problem; Product Quality Problem; Structural Problem

  NEEDED TO TAKE BIOPSIES DURING AN ENDOSCOPY. BIOPSY FORCEPS PACKAGE OPENED AND FORCEPS WERE FOUND TO HAVE JAWS LOCKED IN OPEN POSITION AND WHEN HANDLE OPEN AND CLOSED, THE JAWS MOVED SIDE TO SIDE, DID NOT OPEN AND CLOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838764 ↗
• InjuryMar 13, 2025Adverse 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 FORCEPS WAS USED DURING A GASTROSCOPY AND COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FORCEPS COMPLETELY REMOVED THE MUCOSA AND SUBMUCOSA, WITH A 4 MM PUNCH SPECIMEN. THE BIOPSY SITE WAS LOST NECESSITATING AN EXPLORATION OF THE DUODENUM FOR 20 MINUTES, BUT THE SITE WAS LOST. THIS LED TO SEVERAL POSTOPERATIVE COMPLICATIONS, INCLUDING PAIN, THE NEED FOR A CT SCAN, NASOGASTRIC TUBE PLACEMENT, PROLONGED FASTING IN AN UNDERNOURISHED PATIENT, AND ANTIBIOTIC TREATMENT, ULTIMATELY EXTENDING HOSPITALIZATION BY THREE DAYS. CT FINDINGS SUGGEST THE PRESENCE OF A FEW EXTRA DIGESTIVE AIR BUBBLES, NOTABLY PERIDUODENAL, PERIVESICULAR, AND SUPRAHEPATIC, ASSOCIATED WITH A SMALL AMOUNT OF INTRAPERITONEAL FLUID IN THE DOUGLAS POUCH, INDICATING A POST-BIOPSY DIGESTIVE PERFORATION. THE PATIENT WAS GIVEN MORPHINE FOR PAIN MANAGEMENT. FOR ANTIBIOTIC THERAPY, THE PATIENT WAS GIVEN ROCEPHIN AND FLAGYL FOR 7 DAYS. THE PATIENT'S CONDITION IMPROVED, AND THEY WERE DISCHARGED TO A REHABILITATION CENTER ON FEBRUARY 3, 2025, WITH NO FURTHER FOLLOW-UP NEEDED RELATED TO THE EVENT.

  Patient problems: Pain; Perforation

  MAUDE report 21591708 ↗
• MalfunctionJan 28, 2025

  WHILE PREFORMING A BIOPSY IN ENDOSCOPY IT WAS OBSERVED THAT THE RADIAL JAW LARGE CAPACITY WITH NEEDLE BIOPSY FORCEP WAS MISSING ONE SIDE OF THE FORCEP. PRODUCT WAS THROWN AWAY AND A NEW DEVICE WAS OPENED AND USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251463 ↗
• MalfunctionJul 5, 2024Device 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 LARGE CAPACITY FORCEPS WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS REPORTED THAT A PLASTIC PIECE WAS ATTACHED TO THE CUPS OF THE BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE DEVICE WAS PROVIDED BY THE ACCOUNT SHOWING THE DEVICE INSIDE THE PATIENT WITH AN UNKNOWN MATERIAL ATTACHED TO THE CUPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19680511 ↗
• MalfunctionDec 18, 2023

  BIOPSY FORCEPS NEEDLE APPEARED TO BE BENT TO THE SIDE WHEN PLACED IN SCOPE IN PATIENT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357634 ↗
• MalfunctionFeb 20, 2023Difficult to Open or Close; Device Contamination with Chemical or Other Material; Difficult to Open or Close; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 LARGE CAPACITY BIOPSY FORCEPS WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE RADIAL JAW 4 BIOPSY FORCEPS WERE HARD TO OPEN. ADDITIONALLY, SOMETHING STICKY WAS OBSERVED ON THE JAWS OF THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404274 ↗
• MalfunctionJan 28, 2022Material Protrusion/Extrusion

  BIOPSY FORCEP NOTED BY DOCTOR DURING A PROCEDURE TO HAVE A PIECE OF METAL STICKING OUT BY THE FORCEP TIP. DISCONTINUED USE ONCE NOTED AND REPLACED ITEM WITH A NEW ONE. RADIAL JAW WITH NEEDLE 2.8MM, LOT # 28256175, EXP 10/22/2024. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13393794 ↗
• InjuryDec 8, 2020Break

  DURING EGD PROCEDURE THE NEEDLE TIP OF THE FORCEP BROKE OFF IN PT'S ESOPHAGUS. NO APPARENT INJURY AT TIME OF PROCEDURE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10975640 ↗
• InjuryJul 16, 2020Break

  BIOPSY FORCEPS TIP AND NEEDLE BROKE OFF WHILST TAKING A BIOPSY FROM THE PATIENTS STOMACH. THOROUGH INSPECTION OF THE PATIENTS STOMACH AND DUODENUM CARRIED OUT. LOCATED THE SPIKE AND REMOVED USING A NEW SET OF FORCEPS. REPORTED TO THE MANUFACTURER VIA THE REPRESENTATIVE. FDA SAFETY REPORT ID #: (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10288859 ↗
• MalfunctionDec 16, 2019Entrapment of Device

  DURING INTRA-OP ENDOSCOPY, SURGEON PLACED RADIAL JAW BIOPSY FORCEP INTO LUMEN OF GASTROSCOPE TO OBTAIN A SPECIMEN. SURGEON WAS SUCCESSFUL IN OBTAINING BIOPSY, BUT THE BIOPSY FORCEP ENDED GETTING STUCK INSIDE OF THE GASTROSCOPE. SCOPE WILL BE SENT TO OLYMPUS FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9474125 ↗
• MalfunctionApr 27, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #3005099803-2018-01418 FOR THE FIRST RADIAL JAW¿ 4 BIOPSY FORCEPS AND MANUFACTURER REPORT#3005099803-2018-01419 FOR THE SECOND RADIAL JAW¿ 4 BIOPSY FORCEPS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RADIAL JAW¿ 4 BIOPSY FORCEPS WAS USED IN THE STOMACH DURING A ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, A STICKY GLUE WAS FOUND ON THE FORCEPS. THE FORCEPS WAS NOT USED IN THE PATIENT AND WAS DISCARDED. ANOTHER PACKAGE WAS OPENED AND FOUND GLUE ON THE FORCEPS AS WELL. THE PROCEDURE WAS COMPLETED WITH THE THIRD RADIAL JAW FORCEPS. 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 ¿FINE¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7469076 ↗
• MalfunctionApr 26, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #3005099803-2018-01418 FOR THE FIRST RADIAL JAW¿ 4 BIOPSY FORCEPS AND MANUFACTURER REPORT#3005099803-2018-01419 FOR THE SECOND RADIAL JAW¿ 4 BIOPSY FORCEPS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RADIAL JAW¿ 4 BIOPSY FORCEPS WAS USED IN THE STOMACH DURING A ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, A STICKY GLUE WAS FOUND ON THE FORCEPS. THE FORCEPS WAS NOT USED IN THE PATIENT AND WAS DISCARDED. ANOTHER PACKAGE WAS OPENED AND FOUND GLUE ON THE FORCEPS AS WELL. THE PROCEDURE WAS COMPLETED WITH THE THIRD RADIAL JAW FORCEPS. 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 ¿FINE¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7467319 ↗
• InjuryNov 21, 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 WITH NEEDLE BIOPSY FORCEPS WAS USED IN THE DUODENUM DURING A OESOPHAGO-GASTRODUODENOSCOPY (OGD) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED MELENA AFTER THE PROCEDURE AND WENT TO THE ER. ADDITIONALLY, IT WAS REPORTED THAT THERE WERE NO ISSUES NOTED ON THE DEVICE AT THE TIME OF PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7051872 ↗
• InjuryNov 21, 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 WITH NEEDLE BIOPSY FORCEPS WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017 THE PATIENT NOTED FRESH BLOOD DURING BOWEL MOVEMENT THREE TIMES. MOREOVER, PATIENT NOTED A LOT OF BRIGHT RED BLOOD WITH ASSOCIATED PAIN ON THE THIRD TIME. PATIENT WAS ADVISED BY THE DEPARTMENT TO GO TO THE ER. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS NO MALFUNCTION OR DAMAGE NOTED ON THE DEVICE DURING THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7051854 ↗
• MalfunctionJun 7, 2016Bent

  DURING PROCEDURE (EGD WITH MAC ANESTHESIA), ESOPHAGEAL SPECIMENS WERE BEING OBTAINED. AFTER OBTAINING A FEW SPECIMENS, DOCTOR NOTED/STATED THE NEEDLE OF THE BIOPSY FORCEPS WAS BENT AND REQUESTED ANOTHER FORCEPS. OLD FORCEPS WAS SET ASIDE AND FURTHER BIOPSIES OBTAINED WITH NEW FORCEPS PER DOCTOR WITHOUT PROBLEM. PROCEDURE WAS COMPLETED WITHOUT INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5707093 ↗
• InjuryJun 7, 2016Break; Component Missing; Material Protrusion/Extrusion

  DOCTOR DOING COLONOSCOPY AS DOING BX, WHEN CLAMPED DOWN ON JAW OF FORCEP NOTED THAT NEEDLE STICKING OUT TO SIDE OF FORCEP, WHEN WITHDREW BX FORCEP NEEDLE NOT PRESENT. THE SCOPE WENT TO SPS, RUN BRUSH THROUGH AND DID NOT FIND NEEDLE. ACCORDING TO TECH THE SCOPE WAS DAMAGED, SPS TECH STATED THAT EVIDENCE OF SCOPE PUNCTURE PRESENT. REASON FOR USE: ENDOSCOPY. IS THE PRODUCT COMPOUNDED? NO. IS THE PRODUCT OVER-THE-COUNTER? NO. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

  Patient problems: No Information

  MAUDE report 5707041 ↗