PKG, 5MM MULTI-FUNCTION PEEK HANDLE

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE WAS INSERTED INTO THE ABDOMEN DURING SURGERY. DURING USAGE OF THE INSTRUMENT, THE TIP OF IT SNAPPED ON ONE SIDE AND WAS HANGING. SURGEON SUCCESSFULLY PULLED THE INSTRUMENT OUT WITHOUT LEAVING ANY PIECES BEHIND.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.