120MM INSUFF NEEDLE

Additional Manufacturer Narrative

COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. IT IS ANTICIPATED THAT THE DEVICE INVOLVED IN THE COMPLAINT SHALL BE RETURNED BY THE CUSTOMER UNDER RMA 269762. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. REFERENCE (B)(4). ***UPDATE*** INVESTIGATION INITIATED MANUFACTURER'S INVESTIGATION: NO SAMPLE RETURNED. *ANALYSIS AND FINDINGS: THE REPORTED EVENT THAT THE DEVICE DID OCCLUDE CANNOT BE CONFIRMED DUE TO THE ABSENCE OF THE AFFECTED DEVICE AT THE TIME OF THIS INVESTIGATION. THE AFFECTED DEVICE WAS NOT RETURNED FOR INVESTIGATIVE ANALYSIS REVIEW. HOWEVER, IF THE AFFECTED CANNULA IS MADE AVAILABLE FOR INVESTIGATIVE ANALYSIS THE COMPLAINT MAY BE REOPENED AND ADDRESSED AS NEEDED. INVENTORY REVIEW HAS INDICATED THAT LOT 208315 HAS BEEN DEPLETED AND NO LONGER AVAILABLE FOR SAMPLING. REVIEW OF PRODUCT COMPLAINT HISTORY INDICATED THAT THIS HAS BEEN THE FIRST REPORTED EVENT FOR THE PRODUCT # 900-200 120MM INSUFFLATE NEEDLE; THERE ARE NO RECORDS AVAILABLE OF ANY PREVIOUSLY REPORTED EVENTS. THE PRODUCT IS SAMPLED AT INCOMING INSPECTION AND THERE HAS BEEN NO ISSUES REPORTED; ROOT CAUSE FOR THE REPORTED EVENT IS INDETERMINABLE. CORRECTIVE ACTIONS CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME DUE TO THE ABSENCE OF THE AFFECTED DEVICE. REASON: THIS COMPLAINT WILL BE MONITORED FOR TRENDING IN THAT NO INJURY WAS REPORTED TO END USER OR PATIENT. *WAS THE COMPLAINT CONFIRMED? NO.

Description of Event or Problem

REFERENCE (B)(4). "INCREASING PROBLEM, USED TO BE TWO OR THREE BAD ONE'S PER YEAR,THEN HAD SEVERAL IN PAST TWO MONTHS, NOW THREE IN ONE CASE. SOME OF OUR SURGEONS PERFORM AN OCCLUSION TEST ON THE FIELD PRIOR TO UTILIZING THE VERESS NEEDLE. THE GOAL OF THE OCCLUSION TEST IS TO ENSURE THAT A HIGH PRESSURE ALARM IS TRIGGERED ON THE INSUFFLATOR PRIOR TO USING THE NEEDLE. IN EACH CASE, SOMETIMES FOLLOWING THE USE OF SEVERAL NEEDLES, THEY WERE ABLE TO TRIGGER THE HIGH PRESSURE ALARM RULING OUT AN ISSUE WITH THE INSUFFLATOR."

Additional Manufacturer Narrative

COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. IT IS ANTICIPATED THAT THE DEVICE INVOLVED IN THE COMPLAINT SHALL BE RETURNED BY THE CUSTOMER UNDER RMA 269762. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. REFERENCE E-COMPLAINT-(B)(4)

Description of Event or Problem

REFERENCE E-COMPLAINT-(B)(4). "INCREASING PROBLEM, USED TO BE TWO OR THREE BAD ONE'S PER YEAR,THEN HAD SEVERAL IN PAST TWO MONTHS, NOW THREE IN ONE CASE. SOME OF OUR SURGEONS PERFORM AN OCCLUSION TEST ON THE FIELD PRIOR TO UTILIZING THE VERESS NEEDLE. THE GOAL OF THE OCCLUSION TEST IS TO ENSURE THAT A HIGH PRESSURE ALARM IS TRIGGERED ON THE INSUFFLATOR PRIOR TO USING THE NEEDLE. IN EACH CASE, SOMETIMES FOLLOWING THE USE OF SEVERAL NEEDLES, THEY WERE ABLE TO TRIGGER THE HIGH PRESSURE ALARM RULING OUT AN ISSUE WITH THE INSUFFLATOR."