MEDLINE RENEWAL REPROCESSED ETHICON XCEL TROCAR

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO MEDLINE RENEWAL FOR EVALUATION. WE CONFIRMED THAT THE TROCAR IN QUESTION WAS REPROCESSED ONE TIME, AND WE CONFIRMED THE SUTURE STAYS LOCATED ON THE ADJUSTABLE FIXATION PLUG WERE BROKEN UPON RECEIPT. THE DEVICE WENT THROUGH A THOROUGH INSPECTION AND OTHER THAN THE SUTURE STAYS THAT BROKE OFF THE DEVICE, ALL OTHER DEVICE COMPONENTS MET ESTABLISHED INSPECTION CRITERIA PRIOR TO INITIAL PACKAGE AND RELEASE UNFORTUNATELY, MEDLINE RENEWAL DOES NOT HAVE ENOUGH INFORMATION TO DETERMINE THE ACTUAL ROOT CAUSE OF THE FAILURE. MEDLINE RENEWAL CONFIRMED THAT NO ADVERSE PATIENT CONSEQUENCE, PROCEDURAL DELAY, OR MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE DEVICE FAILURE. THEREFORE IN AN ABUNDANCE OF CAUTION, MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT. (B)(4).

Description of Event or Problem

MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT THE SUTURE STAYS LOCATED ON THE ADJUSTABLE FIXATION PLUG OF A REPROCESSED ETHICON XCEL TROCAR, MODEL H12LP, DETACHED DURING USE. THE COMPONENT IS USED TO SECURE SUTURE DURING THE COURSE OF THE SURGERY. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE, THEREFORE THERE WAS NO ADVERSE PATIENT CONSEQUENCE, PROCEDURAL DELAY OR MEDICAL INTERVENTION REQUIRED.