inforMED
MalfunctionDWZ

RADIAL JAW PULMONARY 3

Received Sep 11, 2006

Report 6000150-2006-00002 · MDR key 882285

Device

Generic name

Biopsy Forceps

Model number

*

Catalog number

1523

Lot number

559434

Product problems

  • Wire(s), breakage of
  • Device Issue

Patient

YR

  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

THE COMPLAINT IS CONFIRMED. BASED ON INVESTIGATION, THE COMPLAINT SAMPLE RETURNED DOES NOT CLOSE PROPERLY DUE TO PULL WIRE BROKEN. HOWEVER, THERE IS NOT ENOUGH EVIDENCE TO DETERMINE THE CAUSE OF FAILURE OF THE DEVICE. OUR DIRECTIONS FOR USE OUTLINE APPROPRIATE PLACEMENT, ACCESS AND MAINTENANCE PROCEDURES.

Description of Event or Problem

THE COMPLAINANT REPORTED THAT THE RADIAL FORCEP WOULD NOT CLOSE AND COULD NOT BE PUT THROUGH THE SCOPE DURING PREPARATION. NO PT COMPLICATIONS DUE TO THE REPORTED MALFUNCTION.