MalfunctionGAS
US SURGICAL -COVIDIEN- AUTOSUTURE
Received Mar 11, 2010 · Event occurred Feb 22, 2010
Report MW5015159 · MDR key 1633087
Device
Generic name
Suture Surgidac 2-0 48" Endo
Manufacturer
CovidienProduct problems
- Device Dislodged or Dislocated
Patient
74 YR
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
DURING LAPAROSCOPIC PROCEDURE, THE NEEDLE BECAME LODGED IN THE DIAPHRAGM. THE SURGEON ATTEMPTED TO REMOVE THE SUTURE BACKWARDS AND THE NEEDLE DISPLACED FROM THE THREAD. THE SURGEON MADE THE DECISION TO LEAVE THE NEEDLE IN PLACE, AS FURTHER EXPLORATION WOULD WEAKEN HIS REPAIR OF THE PATIENT'S HIATAL HERNIA.