CORE TRUMPT 5MMX32CM FOR 1OR 2BAG 10/BOX

Description of Event or Problem

CONMED (B)(4) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, CD8190, CORE TRUMPT 5MMX32CM WAS BEING USED ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED THE SUCTION WAS ACTIVATED DESPITE THE BUTTON WAS NOT PUSHED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. AFTER FURTHER ASSESSMENT IT WAS FOUND, THERE WAS NO DELAY TO THE PROCEDURE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

Additional Manufacturer Narrative

THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. DEVICE NOT YET RECEIVED.

Description of Event or Problem

CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, CD8190, CORE TRUMPT 5MMX32CM WAS BEING USED ON 13DEC21 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED THE SUCTION WAS ACTIVATED DESPITE THE BUTTON WAS NOT PUSHED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. AFTER FURTHER ASSESSMENT IT WAS FOUND, THERE WAS NO DELAY TO THE PROCEDURE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

Additional Manufacturer Narrative

REPORTED EVENT OF THE DEVICE SELF-ACTIVATING IS UNCONFIRMED. RECEIVED TWO CD8190 IN UNORIGINAL PACKAGING. LOT NUMBER WAS NOT VERIFIED. PERFORMED A VISUAL INSPECTION, THE DEVICES WERE RECEIVED WITH THE TUBING CUT OFF. THERE ARE NO OTHER OBVIOUS SIGNS OF ABNORMALITIES OR DEFECTS. A FUNCTIONAL INSPECTION COULD NOT BE PERFORMED DUE TO THE MISSING TUBING. A TWO-YEAR LOT HISTORY REVIEW COULD NOT BE PERFORMED SINCE A LOT NUMBER WAS NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY REVIEW COULD NOT BE PERFORMED SINCE A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 10 REPORTS, REGARDING 30 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 703,810 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.00004. CONMED ENCOURAGES THE INSPECTION AND/OR TEST OF ALL MEDICAL EQUIPMENT PRIOR TO USE TO ENSURE ALL DEVICES ARE FUNCTIONING AS EXPECTED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.