LACRIMAL INTUBATION SET, CRAWFORD TYPE

Additional Manufacturer Narrative

ALTHOUGH THE CUSTOMER DID NOT REPORT A LOT # OF THE INVOLVED PRODUCT, THE RETURNED SAMPLES WERE IN A BOX WITH LOT ID OF 60103C. THE DEVICE HISTORY RECORDS FOR LOT # 60103CC WERE REVIEWED, THE INSPECTION REPORT SHOWED THAT NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED TO THE COMPLAINT CONDITION INSPECTION OF THE SAMPLES INDICATE THAT THE SAMPLES HAVE BEEN USED, THE STEEL USED FOR THIS DEVICE IS SOFT BUT FIRM ENOUGH. WHILE THE DEVICE IS DESIGNED TO PROVIDE EASE OF PLACEMENT AND ENHANCED STENTING EFFECT IN POST DCR PROCEDURES TO PREVENT POSTOPERATIVE PROLAPSE THE PLIABILITY OF THE PRODUCT IS NEEDED TO MANEUVER THE DEVICE THROUGH HARD ANATOMICAL STRUCTURES. AS THE STEEL PROBES ARE VERY THIN, THEY BEND IF HIT AGAINST THE BONY PROMINENCES, THEREFORE, DEPENDING UPON THE SURGEON PREFERENCE, THE PUNCTA AND THE CANALICULI MAY OR MAY NOT BE DILATED BEFORE THE PLACEMENT OF THE DEVICE BUT IS NOT REQUIRED. QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem

THE INTERNATIONAL DISTRIBUTOR (B)(6) REPORTED AN ISSUE ENCOUNTERED BY ONE OF THEIR CUSTOMERS WHILE USING THE DEVICE. THE REPORT STATED THAT THE STAINLESS STEEL WAS TOO SOFT, THAT IT WAS NOT EASY TO INTUBATE, AND THAT IT WAS DEFORMED. DESPITE MULTIPLE REQUESTS TO THE DISTRIBUTOR FOR ADDITIONAL INFORMATION THERE WAS NONE PROVIDED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.