INVESTIGATION SUMMARY AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THE TIP OF A LAPAROSCOPIC KITTNER DISSECTOR (PART NUMBER 28-0801) CAME OFF THE PRODUCT DURING A PROCEDURE. THE REPORTED ISSUE CAUSED A TWO-HOUR DELAY AND REQUIRED ADDITIONAL SEDATION FOR THE PATIENT. THE TIP WAS FOUND INSIDE THE TROCAR. INITIALLY, SAMPLES WERE REPORTED TO BE AVAILABLE. HOWEVER, PICTURES OF THE DEFECTIVE PRODUCT WERE PROVIDED INSTEAD. THE FINISHED GOOD LOT NUMBER WAS REPORTED, AND THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. (B)(4) SUPPLIES THE DISSECTOR TO DEROYAL INDUSTRIES. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (B)(4) AND IS DUE MARCH 3, 2017. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. THE 2014-2017 SCAR AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. SIMILAR COMPLAINTS WERE IDENTIFIED IN 2016. THE PRODUCT HAS BEEN PLACED UNDER PURCHASE INSPECTION AS A RESULT OF PREVIOUS COMPLAINTS. THE INVESTIGATION IS INCOMPLETE AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
D
Patient 1
THE TIP OF A DISSECTOR WAS DISCOVERED MISSING DURING A LAPAROSCOPIC SURGERY ON A CHILD. IT DELAYED THE SURGERY BY TWO HOURS AND REQUIRED ADDITIONAL SEDATION FOR THE PATIENT. THE STAFF USED A C-ARM TO TRY TO FIND THE MISSING TIP. IT DID NOT SHOW UP WITH THE C-ARM. IT WAS IDENTIFIED WITH A PLATE X-RAY AND FOUND TO BE INSIDE OF THE TROCAR.
N
Patient 1
ROOT CAUSE: THE KITTNER DISSECTOR IS SUPPLIED TO DEROYAL BY (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (B)(4). IN ITS RESPONSE, (B)(4) STATED ITS INVESTIGATION DETERMINED SOME GLUE OPERATORS USED A SLIGHTLY VARIED METHOD OF WRAPPING TAPE ON THE END OF THE STICK. THIS VARIATION LEFT THE POTENTIAL FOR GLUE TO BE IN THE INCORRECT AREA OF THE TAPE. ADDITIONALLY, A GAP WAS IDENTIFIED IN THE TRAINING OF THE OPERATORS WHO HAD BEEN IN THE POSITION FOR LESS THAN ONE YEAR. CORRECTIVE ACTION: IN THE SCAR RESPONSE, (B)(4) HAS IDENTIFIED THE FOLLOWING CORRECTIVE ACTIONS: ADD MORE DETAILS TO THE MANUFACTURING PROCEDURE (MANUFACTURING OF ENDOKITTNER PC3060 REV. Q) TO CLARIFY THE STEPS OF THE GLUING PROCESS; RETRAIN ALL OPERATORS ON PROPER TIP FOLDING, GLUING, AND WRAPPING TECHNIQUES; AND SUPERVISOR WILL FOLLOW-UP TO ENSURE ALL OPERATORS ARE TRAINED ON THE MANUFACTURING PROCEDURE AND RELATED QUALITY DOCUMENTATION. ALL CORRECTIVE ACTIONS WERE DOCUMENTED IN (B)(4). CORRECTIONS: IN THE SCAR RESPONSE, (B)(4) STATED PERSONNEL INVOLVED WERE NOTIFIED THROUGH WRITTEN NOTIFICATION ABOUT THE NON-CONFORMITY; INVENTORY VERIFICATION AT THE (B)(4) WAREHOUSE WAS PERFORMED AND LOTS 4K303 AND 16H3290 WERE REINSPECTED AT 100 PERCENT; DEROYAL RETURNED LOTS 16F2326, 16H3290, 16D1367 AND 16B0344 FOR REINSPECTION AT 100 PERCENT. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED INDICATING THE TIP OF A LAPAROSCOPIC KITTNER DISSECTOR (PART NUMBER 28-0801) CAME OFF THE PRODUCT DURING A PROCEDURE. THE REPORTED ISSUE CAUSED A TWO-HOUR DELAY AND REQUIRED ADDITIONAL SEDATION FOR THE PATIENT. THE TIP WAS FOUND INSIDE THE TROCAR. INITIALLY, SAMPLES WERE REPORTED TO BE AVAILABLE. HOWEVER, PICTURES OF THE DEFECTIVE PRODUCT WERE PROVIDED INSTEAD. THE FINISHED GOOD LOT NUMBER WAS REPORTED, AND THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. (B)(4) SUPPLIES THE DISSECTOR TO DEROYAL INDUSTRIES. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (B)(4) AND RETURNED ON FEBRUARY 15, 2017. THE 2014-2017 SCAR AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. SIMILAR COMPLAINTS WERE IDENTIFIED IN 2016. THE PRODUCT HAS BEEN PLACED UNDER PURCHASE INSPECTION AS A RESULT OF PREVIOUS COMPLAINTS. PREVENTIVE ACTION: IN THE SCAR RESPONSE, (B)(4) STATED THE AREA SUPERVISOR FOLLOWED UP WITH EACH OPERATOR TO ENSURE THE GLUING PROCESS IS PERFORMED CORRECTLY. THE PRODUCTION INSPECTOR WILL CONTINUE TO CHECK ALL STICKS FOR TIP RETENTION. ALL PREVENTIVE ACTIONS WERE DOCUMENTED IN (B)(4). THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
D
Patient 1
THE TIP OF A DISSECTOR WAS DISCOVERED MISSING DURING A LAPAROSCOPIC SURGERY ON A CHILD. IT DELAYED THE SURGERY BY TWO HOURS AND REQUIRED ADDITIONAL SEDATION FOR THE PATIENT. THE STAFF USED A C-ARM TO TRY TO FIND THE MISSING TIP. IT DID NOT SHOW UP WITH THE C-ARM. IT WAS IDENTIFIED WITH A PLATE X-RAY AND FOUND TO BE INSIDE OF THE TROCAR.