BIOPSY FORCEPS, FLEXIBLE, 3 FR.

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "GRASPING MECHANISM OF THE INSTRUMENT BROKE WHILST IN USE ON A PATIENT. THE SURGEON NEEDED TO CLOSE THE JAWS TO SAFELY REMOVE THEM FROM THE PATIENT, BUT STRUGGLED TO DO SO. THEY MANAGED TO CLOSE THE JAW, REMOVE THE INSTRUMENT, AND PROCEED WITH THE CASE USING A SECOND INSTRUMENT." THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

Additional Manufacturer Narrative

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