MICRODIGITAL IP 4.1 CAMERA HEAD
Received Nov 6, 2000 · Event occurred Oct 2, 2000
Report 2020483-2000-00006 · MDR key 304000
Device
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.