Radial Jaw 4 M00515030Recalls & reported problems
Boston Scientific Corporation · Single-Use Biopsy Forceps · Class 2
All models of Radial Jaw 4 (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Boston Scientific Radial Jaw 4 is a single-use biopsy forceps used to take tissue samples during endoscopy. Most of the 29 reports describe problems found while opening the package — tears or holes in the sterile packaging, a hair-like object inside the bag — with no patient involved. A few describe the jaw bending inside a patient and having to be broken to free it from the endoscope. There were no deaths, 1 injury, and 27 malfunctions, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08714729821700), received between Jul 18, 2017 and Feb 1, 2024 — classified as 1 injury, 27 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (26 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.
Reports received per month
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging26
- Device Contaminated During Manufacture or Shipping1
- Inappropriate/Inadequate Shock/Stimulation1
- Material Twisted/Bent1
Patient problems
- No Patient Involvement26
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS WAS TO BE USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING UNPACKING, A HAIR-LIKE OBJECT WAS FOUND INSIDE THE BAG BEFORE OPENING THE STERILE PACKAGE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18627867 ↗Apr 28, 2020Material Twisted/Bent
THE SURGEON STATED THAT THE CLAMP/ JAW PORTION OF THE FORCEPS BENT WHILE INSIDE OF THE PATIENT, THE FORCEPS AND ENDOSCOPE WAS THEN REMOVED FROM THE PATIENT. THE CLAMP/ JAW OF THE FORCEPS HAD TO BE BROKEN IN ORDER TO REMOVE THE DEVICE FROM THE ENDOSCOPE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10004672 ↗InjuryMay 17, 2018Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS WAS USED IN A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE END OF THE PROCEDURE, WHEN ATTEMPTING TO REMOVE ONE MORE POLYP, THE ANESTHESIOLOGIST FELT AN ELECTRICAL SHOCK AND A HAIR SINGED OFFED ONE FINGER. THE ANESTHESIOLOGIST WASN¿T WEARING GLOVES WHEN THE SHOCK OCCURRED. FURTHERMORE, HE WASN'T TOUCHING THE PATIENT BUT WAS TOUCHING THE STRETCHER. 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 7521170 ↗MalfunctionFeb 9, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7258998 ↗MalfunctionFeb 9, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7258548 ↗MalfunctionFeb 9, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7258547 ↗MalfunctionFeb 9, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7258543 ↗MalfunctionFeb 9, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7258542 ↗MalfunctionFeb 9, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7258541 ↗MalfunctionFeb 9, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7258540 ↗MalfunctionFeb 9, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7258539 ↗MalfunctionFeb 9, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7258538 ↗MalfunctionFeb 9, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7258537 ↗MalfunctionFeb 9, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7258536 ↗MalfunctionFeb 9, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7258534 ↗MalfunctionFeb 9, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 HOT BIOPSY FORCEPS WAS UNPACKED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7258533 ↗MalfunctionJul 18, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW¿ 4 BIOPSY FORCEPS WAS UNPACKED FOR INVENTORY ON JUNE 20, 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS A TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 6723951 ↗MalfunctionJul 18, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW¿ 4 BIOPSY FORCEPS WAS UNPACKED FOR INVENTORY ON JUNE 20, 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS A TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 6723936 ↗MalfunctionJul 18, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW¿ 4 BIOPSY FORCEPS WAS UNPACKED FOR INVENTORY ON JUNE 20, 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS A TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 6723909 ↗MalfunctionJul 18, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW¿ 4 BIOPSY FORCEPS WAS UNPACKED FOR INVENTORY ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS A TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 6723904 ↗MalfunctionJul 18, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW¿ 4 BIOPSY FORCEPS WAS UNPACKED FOR INVENTORY ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS A TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 6723899 ↗MalfunctionJul 18, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW¿ 4 BIOPSY FORCEPS WAS UNPACKED FOR INVENTORY ON JUNE 20, 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS A TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 6723894 ↗MalfunctionJul 18, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW¿ 4 BIOPSY FORCEPS WAS UNPACKED FOR INVENTORY ON JUNE 20, 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS A TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 6723882 ↗MalfunctionJul 18, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW¿ 4 BIOPSY FORCEPS WAS UNPACKED FOR INVENTORY ON JUNE 20, 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS A TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 6723858 ↗MalfunctionJul 18, 2017Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW¿ 4 BIOPSY FORCEPS WAS UNPACKED FOR INVENTORY ON JUNE 20, 2017. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT THERE WAS A TEAR IN THE DEVICE PACKAGING AND STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 6723857 ↗
Other FORCEPS, BIOPSY, ELECTRIC devices
- HALOGEN LIGHT SOURCE OLYMPUS CLK-4Olympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC65 reports
- Single Use Electrosurgical Hemostatic Forceps FD-410LROlympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC46 reports
- OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5AOlympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC24 reports
- Single Use Electrosurgical Hemostatic Forceps FD-412LROlympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC17 reports
- Single Use Electrosurgical Hemostatic Forceps FD-411UROlympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC15 reports
- SUCTION VALVE MAJ-207Olympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC13 reports
- Captura G31583Cook Incorporated · FORCEPS, BIOPSY, ELECTRIC13 reports
- Single Use Electrosurgical Hemostatic Forceps FD-411QROlympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC10 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page