inforMED
InjuryIXL

DIAGNOST 76 PLUS

Received Mar 12, 1998 · Event occurred Feb 5, 1998

Report 1217116-1998-00006 · MDR key 156154

Device

Generic name

General Purpose R/f System

Model number

9848-500-16202

Catalog number

NA

Lot number

NA

Product problems

  • Installation error
  • Misassembled

Patient

58 YR

  • Dural Tear
  • Tissue Damage
  • Wound Infection

Narrative

Description of Event or Problem

REPORTEDLY, DURING A COLON EXAM, WHEN THE TABLETOP WAS MOVED TOWARDS THE HEAD END, THE PT'S HAND/FINGERS WERE PINCHED BETWEEN THE UNDERSIDE OF THE TABLETOP AND THE TABLE FRAME. REPORTEDLY, THE PT WAS X-RAYED FOR FRACTURES AND THEN WAS TAKEN TO ER FOR POSSIBLE SUTURES. THE PT RETURNED TWO DAYS LATER WITH INFECTION IN TENDON OF PINCHED FINGER REQUIRING IV THERAPY. PT WAS ADMITTED TO HOSP AND REQUIRED SUBSEQUENT SURGERY ON INJURED FINGER TO REMOVE INFECTION. REPORTEDLY, THE TABLETOP WAS FOUND TO BE INSTALLED IN REVERSE.

Remedial action

  • Repair