PNEUMOPERITONEUM NEEDLE

Additional Manufacturer Narrative

OBSERVATION OF FAILURE: IT HAS BEEN CLAIMED BY THE CUSTOMER THAT THE NEEDLE SPRINGS DID NOT RETRACT. THE PROBLEM WAS DUPLICATED ON RETURNED UNITS. CAUSE OF FAILURE: NEEDLE - HOUSING ASSEMBLY IS NOT ALIGNED WITH STYLET - SPRING HOUSING ASSEMBLY. THIS MISALIGNMENT OF TWO ASSEMBLIES INCREASES THE FRICTION BETWEEN NEEDLE AND STYLET, CAUSING THE STYLET NOT TO RETRACT. SHORT TERM CORRECTIVE ACTION: ALL SUSPECT UNITS HAVE BEEN RECALLED. LONG TERM CORRECTIVE ACTION: A. FINAL INSPECTION MPI #860 HAS BEEN MODIFIED TO ENSURE INSPECTING 100% FUNCTIONALLY OF THE PRODUCT. A PDR IS BEING USED, PENDING THE ECO APPROVAL. B. TOOLING FOR NEEDLE - HOUSING ASSEMBLY HAS BEEN MODIFIED TO ENSURE CONCETRICITY BETWEEN NEEDLE AND HOUSING. C. SPRING HOUSING ID HAS BEEN CHANGED FROM .126 +/- .002 TO .118 +/- -002. THIS CHANGE HAS BEEN SUCCESSFULLY VALIDATED. ALL THESE CHANGES WILL BE RELEASED THROUGH AN ENGINEERING CHANGE ORDER. EXPECTED DATE IS 8/31/97.

Description of Event or Problem

DURING A LAPAROSCOPIC NISSEN PROCEDURE, THE NEEDLE STYLET ALLEGEDLY FAILED TO RETURN TO ITS PROPER PLACE TO COVER THE NEEDLE.