INNER SHEATH FOR 27050 SC

Additional Manufacturer Narrative

ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION AND TO HAVE DEVICE RETURNED FOR EVALUATION; HOWEVER, THERE HAS BEEN NO RESPONSE FROM THE REPORTER AT THE TIME OF THIS REPORT. ONCE THE EVALUATION IS COMPLETED OR IF NEW INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WOULD BE MADE TO THE FDA. THIS COMPLAINT WILL BE TRACKED AND TRENDED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)4).

Description of Event or Problem

IT WAS REPORTED THAT THE TIP OF INNER SHEATH BROKE OFF DURING SURGERY. THE SURGEON COULD NOT RETRIEVE THE BROKEN PIECE BECAUSE THE BROKEN PIECE COULD NOT BE VISUALIZED ON THE MONITOR. NO ADDITIONAL INFORMATION WAS PROVIDED.