inforMED
MalfunctionFFF

BOSTON SCIENTIFIC RADIAL JAW 4 2.8 MM LARGE

Received Jun 7, 2016 · Event occurred May 24, 2016

Report MW5062736 · MDR key 5707093

Device

Generic name

Radial Jaw

Manufacturer

Boston Scientific

Lot number

19148700

Product problems

  • Bent

Patient

53 YR

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

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.