US ENDOSCOPY RECEIVED FDA NOTIFICATION THAT AN MDR WHICH HAD BEEN FILED BY A CLINICAL USER (UF/IMPORTER REPORT # 4506770000-2014-8002). THE USER REPORTED DAMAGE TO PATIENT DENTITION DURING USE OF BITE BLOCK - MAXI (00712804). THE MDR EVENT DESCRIPTION INCLUDES: 'WE ARE INVESTIGATING AND TRAILING A NEW BITE BLOCK WITH A FOAM ELEMENT DUE TO THREE OCCURRENCES OF DENTAL DAMAGE WITH US ENDOSCOPY MAXI BITE BLOCK OVER THE PAST 12 MONTHS. ONE WAS THE DENTAL CROWN AND PART OF THE TOOTH WAS SPAT OUT AFTER THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND CARDIOVERSION ONCE THE PATIENT WOKE UP. THE OTHER TWO WERE DURING REMOVAL OF THE BITE BLOCK AFTER ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURES. WHAT WAS THE ORIGINAL INTENDED PROCEDURE: SCOPE AND DENTAL PROTECTION DURING TEE/CARDIOVERSIONS AND EGD.' THE MDR ADDITIONAL INFORMATION INCLUDES: 'THE PATIENT WAS (B)(6) YEAR OLD FEMALE WITH PREVIOUS DENTAL CROWN ON THIS PARTICULAR PATIENT BUT HAVE HAD TWO OTHER OCCURRENCES.'
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Patient 1
THE BITE BLOCK - MAXI IS A SINGLE PIECE CIRCULAR PLASTIC BITE BLOCK WITH OVAL HOLE (60 FR) IN THE CENTER FOR INSERTION OF THE ENDOSCOPE, AND INCLUDES RETENTION STRAP. THE BITE BLOCK IS USED TO PROTECT THE ENDOSCOPE INSERTION TUBE FROM BEING BITTEN BY THE PATIENT. WARNINGS AND PRECAUTIONS FOUND IN THE INSTRUCTIONS FOR USE INCLUDE: WHEN PLACING THE BITE BLOCK IN THE PATIENT'S MOUTH, CARE SHOULD BE EXERCISED TO AVOID PLACING FINGERS BETWEEN THE BITE BLOCK AND THE PATIENT'S TEETH. FLEXIBLE ENDOSCOPY PROCEDURES SHOULD ONLY BE PERFORMED BY PERSONS HAVING ADEQUATE TRAINING AND FAMILIARITY WITH ENDOSCOPIC TECHNIQUES. CONSULT THE MEDICAL LITERATURE RELATIVE TO TECHNIQUES, COMPLICATIONS AND HAZARDS PRIOR TO THE PERFORMANCE OF AN ENDOSCOPIC PROCEDURE. THE DEVICE LOT NUMBER WAS NOT IDENTIFIED AND THE DEVICE WAS NOT RETURNED FOR EXAMINATION. THE CLINICAL USER REPORT DOES NOT INDICATE A MALFUNCTION OF THE DEVICE (SUCH AS CRACKING OR COLLAPSE) WHICH COULD CONTRIBUTE TO DENTAL DAMAGE. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.