N20 HAMMHD RET PBE STRT

Description of Event or Problem

BLACK SPECS COMING OFF PROBE TIP. FS LOG# (B)(4). N20 HAMMHD RET PBE STRT 144 (B)(4).

Additional Manufacturer Narrative

COOPERSURGICAL, INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

Additional Manufacturer Narrative

INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES. *ANALYSIS AND FINDINGS (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 06/28/2021 UNDER WO #(B)(4) AND SHIPPED ON (B)(6) 2022. MANUFACTURING RECORD REVIEW: DHR 303655 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED NO SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 98767, THIS UNIT WAS AT CSI ON 7/13/2022. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. HOWEVER, THE UNIT DID HAVE DARK MATERIAL ON THE TIP. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. ROOT CAUSE: THIS ISSUE IS ATTRIBUTED TO END USER ERROR DURING CLEANING AND STERILIZATION. THE PROBES ARE USED WITH A SILICON SLEEVE AND TO BE REMOVED WHEN WIPED DOWN PRIOR TO AUTOCLAVING. THIS WILL REMOVE UNWANTED MATERIALS AND PREVENT ANY POTENTIAL FOR TRAPPING MATERIAL BEHIND THE SLEEVE. IT IS EVIDENT MATERIAL WAS NOT REMOVED AND TURNED DARK FROM THE STERILIZATION PROCESS WHICH USES HEAT. AFTERWARDS, WHEN THE DEVICE IS ACTIVATED THE COLD WILL LOOSEN THE MATERIAL AND IT WILL FLAKE OFF. *CORRECTION AND/OR CORRECTIVE ACTION THE UNIT WAS CLEANED, TESTED AND RETURNED TO THE CUSTOMER. THE UNIT WAS NOTED TO REQUIRE AN ADJUSTMENT THOUGHT TO BE DUE TO THE SHAFT NOT BEING FULLY CLEARED IN ASSEMBLY. ALTHOUGH THE PROCESS CLEARING OUT THE SHAFT IS IN PLACE THE METHOD SHEET WAS FURTHER REVIEWED FOR POTENTIAL IMPROVEMENTS AROUND CLEARING THE SHAFT. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

Description of Event or Problem

BLACK SPECS COMING OFF PROBE TIP. FS LOG# 98767. 1216677-2022-00220 (B)(6), (B)(4).