MID LABS

Additional Manufacturer Narrative

CUTTER ID (PROBE ASPIRATION PATH) WAS CLOGGED WITH WHAT APPEARS TO BE A LARGE PIECE OF VITREOUS TISSUE, WHICH CAUSED THE PROBE TO FAIL ASPIRATION TESTING. THE PROBE WAS ALSO RECEIVED WITH NEEDLE HAVING A SLIGHT PERMANENT BEND. NEEDLE WAS ALSO FOUND TO BE DISLODGED FROM THE EPOXY BEAD, PREVENTING THE CUTTER FROM REACHING THE CUTTING EDGE, LEADING TO THE CUT FAILURE OBSERVED. SEPARATION WAS BETWEEN THE EPOXY AND THE SS NEEDLE, NO CRACKS WERE FOUND. THERE IS EVIDENCE THAT THE NEEDLE MAY HAVE BEEN PULLED (DEEP SCRATCHES ALONG NEEDLE LENGTH) BUT IS NOT CLEAR IF THESE ARE FROM THE END USER OR CREATED DURING TUBING MANUFACTURING. VISUAL SAMPLING OF CURRENT 23G NEEDLES DID NOT SHOW ANY SIMILAR SCRATCHES. ADD'L. TESTING SHOW THAT NEEDLE-BODY SUBASSEMBLIES FROM THE SAME LOT HAVE COMPARABLE BOND STRENGTH TO CURRENT SUBASSEMBLIES, INDICATING THAT THERE WAS NO EFFECT TO THE BONDING PROCESS. IT IS UNCLEAR WHEN THE NEEDLE WAS BENT (DURING USE OR SHIPPING) BUT MID VISUALLY INSPECTS PROBES FOR BENDS BEFORE SHIPPING.

Description of Event or Problem

PHYSICIAN ATTEMPTED TO USE CUTTER WITH A BAUSCH & LOMB MILLENIUM 3000 AND IT DID NOT CUT. THE OBSERVATION WAS MADE PRIOR TO USE ON THE PATIENT. THE DEVICE DESCRIPTION IS A 21G, R1, VC (P/N D04681 INTO 252OCE, LOT #12010305). THE PATIENT WAS UNDERGOING SURGERY, AND THE DEVICE STOPPED WORKING. THE REPORT WAS THAT THE CUTTER DOES NOT CUT DURING INITIAL USE. THERE WAS NO REPORTED PATIENT INJURY AND SURGERY WAS COMPLETED. THE INCIDENT WAS REPORTED TO MID LABS ON (B)(6) 2015. THE DEVICE WAS RETURNED TO MID LABS AND RECEIVED ON 06/26/2015.