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Patient 1
THE SUSPECT DEVICE IN THIS REPORTED INCIDENT IS THE CONMED SCOPE SAVER BITE BLOCK COMPROMISED OF A POLYETHYLENE MATERIAL WITH AN ATTACHABLE LATEX-FREE STRAP. THIS IS A SINGLE-USE, DISPOSABLE, NONSTERILE DEVICE INDICATED TO AID IN THE PASSAGE OF AN ENDOSCOPE AND TO PROTECT AN ENDOSCOPE AS IT IS PASSED THROUGH A PATIENT'S MOUTH DURING AN UPPER ENDOSCOPIC PROCEDURE. A DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW WAS NOT POSSIBLE AS THE LOT NUMBER FOR THIS PRODUCT HAS NOT BEEN MADE AVAILABLE. NO LABORATORY EXAMINATION WAS PERFORMED ON THE COMPLAINT PRODUCT, AS NO DEVICE WAS MADE AVAILABLE FOR EXAMINATION OR CONFIRMATION OF DEFECT OR CONFIRMATION OF CONMED PRODUCT. A TWENTY-FOUR (24) MONTH REVIEW OF COMPLAINT HISTORY SHOWS THIS AS AN ISOLATED INCIDENT AND THERE HAVE NOT BEEN ANY OTHER REPORTS OF ANY SKIN REACTION TO THE LATEX-FREE STRAP. THERE MAY BE A MULTIPLE OF POSSIBLE CAUSES EITHER MANUFACTURING OR USER RELATED. IN PROCESS INSPECTION AND VISUAL CHECKS DURING MANUFACTURE WERE ACCOMPLISHED TO ENSURE PROPER PRODUCTION OF THE DEVICES. THE BITE BLOCK STRAP MEETS THE BIOCOMPATIBILITY REQUIREMENTS OF ISO 10993, AND, THE BITE BLOCK STRAP IS PRODUCED FROM LATEX-FREE MATERIALS. POSSIBLE CAUSE COULD BE ALLERGIC REACTION DURING THE OPERATING PROCEDURE TO EITHER THE STRAP OF THE SUSPECT DEVICE, OR, ALLERGIC REACTION TO THE CANNULA FROM ANOTHER MANUFACTURER THAT APPARENTLY WAS IN THE SAME VICINITY OF SKIN CONTACT AS THE REPORTED SUSPECT DEVICE. NO ROOT CAUSES CAN BE CONFIRMED WITHOUT EXAMINATION OF THE PRODUCT. THE COMPLAINT CAN BE NEITHER CONFIRMED NOR UNCONFIRMED AT THIS TIME. AS THIS IS AN ISOLATED INCIDENT, AND, THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED ANY MANUFACTURING DEFECTS WITH THIS COMPLAINT, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. THE PHYSICIAN HAD REQUESTED INFORMATION REGARDING THE MATERIALS THE DEVICE IS MADE OF AND THIS WAS SENT TO THE CARE PROVIDER. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. DEVICE NEVER RETURNED TO CONMED CORP.