inforMED
MalfunctionFWJ

MICRODIGITAL IP 4.1 CAMERA HEAD

Received Nov 6, 2000 · Event occurred Oct 2, 2000

Report 2020483-2000-00006 · MDR key 304000

Device

Generic name

Camera Head

Manufacturer

Circon Video

Model number

NA

Catalog number

MV-10000

Lot number

NA

Product problems

  • Fogging
  • Replace
  • Pressure, insufficient

Patient

40 YR

  • Internal Organ Perforation
  • Therapy/non-surgical treatment, additional
  • Surgical procedure, additional

Narrative

Description of Event or Problem

AT THE START OF A LAPAROSCOPIC TUBAL LIGATION, AFTER THE INITIAL ENTRY INTO THE UMBILICUS, THE CAMERA FOGGED. ANTI-FOG WAS USED ON THE LAPAROSCOPE, BUT THAT DID NOT ADEQUATELY CLEAR THE VIEW. AFTER ENTRY INTO THE ABDOMEN WAS MADE WITH A SECOND INSTRUMENT, THE ABDOMINAL PRESSURE WAS BEING LOST. ALL INSTRUMENTS WERE REMOVED FROM THE ABDOMEN UNTIL ADEQUATE ABDOMINAL PRESSURE COULD BE OBTAINED, THEN THE INSTRUMENTS WERE REINSERTED INTO THE ABDOMEN. IT WAS THEN DISCOVERED THAT THE SMALL BOWEL WAS PERFORATED. AT THAT TIME, THE VIEW WITH THE CAMERA WAS STILL FOGGED. AN OPEN LAPAROTOMY WAS PERFORMED TO REPAIR THE SMALL BOWEL, AND THE PT REMAINED IN THE HOSP FOR TWO DAYS. BEFORE BEING DISCHARGED.