M822 F20

Description of Event or Problem

LEICA MICROSYSTEMS (B)(4) RECEIVED A COMPLAINT FROM THE (B)(6) STATING THAT A PATIENT WAS STRUCK BY A BINOCULAR TUBE THAT FELL FROM THE OPTICS CARRIER OF AN M822 F20. THE PATIENT SUFFERED A LACERATION ABOVE THE EYEBROW WHICH REQUIRED STITCHES. THE BINOCULAR TUBE WAS NOT SECURED CORRECTLY TO THE SYSTEM AS REQUIRED BY THE INSTRUCTIONS FOR USE.

Additional Manufacturer Narrative

THIS IS A COMBINED INITIAL/FINAL REPORT. THE ONSITE INVESTIGATION REVEALED THAT THE M822 F20 DID NOT HAVE ANY DEFECT OR MALFUNCTION. THE REVIEW OF THE COMPLAINT AND MDR DATABASE REVEALED THAT NO (0) SIMILAR OR IDENTICAL EVENT WAS REPORTED FOR THE M822 F20. THE REVIEW OF THE IFU REVEALED, THAT THERE ARE CLEAR WARNINGS OF THE RISK OF INJURY FROM PARTS FALLING DOWN. THE WARNINGS CLEARLY REQUIRE TO MAKE SURE, THAT THE OPTICAL COMPONENTS AND ACCESSORIES ARE INSTALLED PROPERLY. THE INCIDENT IS EVALUATED AS ISOLATED EVENT AND THE WARNINGS IN THE IFU ARE CONSIDERED ADEQUATE TO ADVICE THE USERS ON HOW TO PROPERLY INSTALL OPTICAL ACCESSORIES. IDENTIFIED ROOT CAUSE FOR THE PATIENT INJURY IS, THAT THE USER FAILED TO FOLLOW THE INSTRUCTIONS: THE USER DID NOT INSTALL THE BINOCULAR TUBE AS REQUIRED BY THE IFU. THE IFU REQUIRES TO TIGHTEN THE CLAMPING SCREW. WITHOUT TIGHTENING THE CLAMPING SCREW THE BINOCULAR TUBE WAS LOOSE. SUBSEQUENTLY THE BINOCULAR TUBE FELL DOWN AND CAUSED A PATIENT INJURY. THE USER WAS ADVISED TO FOLLOW THE INSTRUCTIONS FOR USE TO MAKE SURE THAT THE OPTICAL COMPONENTS AND ACCESSORIES ARE INSTALLED PROPERLY.