GRASPING FORCEPS, 3 FR.

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER ON FEBRUARY 19,2025. 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 IN THE BEGINNING OF THE SURGERY, THE CLAMP WORKED CORRECTLY, BUT DURING THE SURGERY, THE CLAMP STOPPED CLOSING WITH THE FORCE THAT IT WAS INITIALLY DOING. SO, THE DOCTORS HAD TO CHANGE THE CLAMP DURING SURGERY. THIS WAS WHAT CAUSED THE PROLONGATION 20-25 MIN OF IT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

Additional Manufacturer Narrative

RESULT OF INVESTIGATION: THE INVESTIGATION OF THE RETURNED PRODUCT REVEALED THAT THE JOINT OF THE PLIERS IS BROKEN, WHICH MEANS THAT IT CAN BE NO LONGER OPENED OR CLOSED. AT THE POINT OF BREAKAGE, IT CAN BE SEEN THAT THE MATERIAL IS BENT TO THE RIGHT, WHICH IS A SIGN THAT THE MATERIAL HAS GIVEN WAY DUE TO EXCESSIVE FORCE. THIS IS CAUSED BY MECHANICAL OVERLOADING OF THE CONNECTION POINT. FOR EXAMPLE, IT CAN OCCUR WHEN GRIPPING UNINTENDED MATERIAL. ALL PRODUCTION RELATED QUALITY CHECKS WERE PASSED, AND NO NON-CONFORMITIES WERE IDENTIFIED IN THE DEVICES MANUFACTURING RECORDS. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).