OPTICAL FORCEPS, FOR BIOPSY
Received Apr 18, 2023 · Event occurred Mar 31, 2023
Report 9610617-2023-00081 · MDR key 16761493
Device
Product problems
- Break
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. PENDING FURTHER RESULTS A SUPPLEMENTAL REPORT WILL BE FILED. THE EVENT IS FILED UNDER INTERNAL (B)(4) COMPLAINT ID: (B)(4).
Description of Event or Problem
THE EVENT OCCURRED IN GREAT BRITAIN. IT WAS REPORTED THAT THE INSTRUMENT FAILED DURING USE. A RIVET FELL OUT. THE RIVET WAS RETRIEVED DURING THE PROCEDURE.
Additional Manufacturer Narrative
IT WAS DETERMINED THAT THE CLAIMED ITEM 27072A WAS DAMAGED BY EXCESSIVE FORCE. EXCESSIVE FORCE WAS EXERTED ON THE JOINT WHERE THE BROKEN AXLE PIN WAS MOUNTED. HERE, THE BORE HAS BEEN THROWN UP AND A DEFORMATION OF THE BORE IS VISIBLE. THIS HAPPENS WHEN, FOR EXAMPLE, TISSUE/CARTILAGE OR SIMILAR IS HELD/PUNCHED IN THE JAW, THIS MATERIAL IS TOO TOUGH/HARD, AND ONE TRIES TO CLOSE THE JAW WITH EXCESSIVE FORCE THROUGH THE HANDLE ANYWAY, THEN THE AXLE PIN PRESSES AGAINST THE HOLE SO LONG AND POWERFULLY UNTIL A THROW-UP OCCURS OR UNTIL THE PIN GIVES WAY AND BREAKS. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Additional Manufacturer Narrative
THIS REPORT IS TO CORRECT SECTION D9 FROM THE LAST SUPPLEMENTAL REPORT THAT WAS SUBMITTED. THE DEVICE WAS RETURNED ON APRIL 17, 2023, NOT MAY 5, 2023. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).