CLAMPING JAW, SMALL

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

DURING THE NEUROSURGICAL INTERVENTION OF COLLOID CYST EXCISION BY VENTRICULAR ENDOSCOPY, THE ENDOSCOPE IS HELD BY A METAL ARM FIXED TO THE INTERVENTION TABLE IN ORDER TO FREE THE SURGEON'S HAND. AT THE END OF THE OPERATION, THE CLAMPING JAW USED TO HOLD THE ENDOSCOPE BROKE, CAUSING MOVEMENT OF THE ENDOSCOPE WHICH WAS IN THE PATIENT'S BRAIN, CAUSING BLEEDING FROM THE EPENDYMAL VEINS AND REDUCING VISIBILITY FOR THE END. INTERVENTION.