WOLF LAPARASCOPIC GRASPING FORCEPS

Additional Manufacturer Narrative

RICHARD WOLF MIC RECEIVED A MEDWATCH REPORT #(B)(4) ON JULY 13, 2020. RICHARD WOLF MIC WILL CONTACT THE USER FACILITY AND MANUFACTURER TO GATHER ADDITIONAL INFORMATION. UPON RECEIPT OF NEW INFORMATION ON A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

SCREW HAD FALLEN OUT OF GRASPER DURING LAPAROSCOPIC PROCEDURE. GRASPER NO LONGER WORKS AND WAS REMOVED FROM PATIENT. SCREW WAS ALSO REMOVED FROM PATIENT. NO PATIENT HARM.

Description of Event or Problem

RWMIC REACHED OUT TO INITIAL REPORTER FOR ADDITIONAL INFORMATION. ACCORDING TO THE INITIAL REPORTER, NO ADDITIONAL INFORMATION CAN BE PROVIDED. ALL THE INFORMATION WERE PROVIDED IN THE MEDWATCH REPORT # 4200070000-2020-8005. RWMIC EVALUATION (B)(6) 2020: THE DEVICE WAS EVALUATED AND THE FOLLOWING WERE RECORDED: FINDINGS: JAWS BROKEN DUE TO MISSING PIN, IT WAS NOTICED THAT FORCEPS WAS OVER FORCED CAUSING JAWS TO BRAKE. THE CONDITION REPORTED BY THE USER FACILITY IS CONFIRMED. PRODUCT DISPOSITION IS SCRAP. POSSIBLE ROOT CAUSE IS THE MISHANDLING OF THE DEVICE BY USER FACILITY.

Additional Manufacturer Narrative

RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. LABELING REVIEW ( GA-E193). CHECKS: CHECK INSTRUMENTS AND ACCESSORIES FOR DAMAGE, HYGIENIC CONDITION AND COMPLETENESS. DO NOT USE INSTRUMENTS WHICH HAVE A DAMAGED CUTTING EDGE. REPLACE DAMAGED INSTRUMENTS. CAUTION! THE INSTRUMENT COULD BECOME KINKED! WHEN WORKING WITH THESE INSTRUMENTS, EXCESSIVE LOAD MAY CAUSE THEM TO BRAKE NEAR THE HANDLE. GUIDE THE DISTAL INSTRUMENT TIP ONLY VIA THE HYSTEROSCOPE OR CYSTOSCOPE SHEATH. NOTE! EXCESSIVE FORCE MAY CAUSE THE INSTRUMENTS TO BRAKE. AS A RESULT OF THE NECESSARY SMALL DIMENSIONS, THE DISTAL SECTIONS OF THE INSTRUMENTS HAVE ONLY LIMITED STABILITY. DO NOT USE THESE INSTRUMENTS FOR GRASPING AND REMOVING OF LARGE PIECES OF TISSUE. IMPORTANT! THE FORCEPS/SCISSORS CANNOT BE DISASSEMBLED. RWMIC CONSIDERS THIS MDR/ COMPLAINT CLOSED. HOWEVER, IN THE EVENT RWMIC RECEIVES ANY ADDITIONAL INFORMATION A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA.