Description of Event or Problem · 1
SITUATION- THE APPLIED DENTAL EXPLORER & PROBE SINGLE USE INSTRUMENTS PRODUCT #D002-008-P ARE NOT STERILE, AND DO NOT HAVE REPROCESSING INSTRUCTIONS PRIOR TO USE. I VERIFIED THIS BY CALLING THE MANUFACTURER AT (B)(6). BACKGROUND- THEY DO MANUFACTURE A SURGICAL SINGLE USE PRODUCT AD SURGICAL D002-009-P I-PAK 3-IN-1 ORAL EXAMINATION PACK, THAT COMES STERILE. HOWEVER THE D002-008-P MENTIONED ABOVE DOES NOT. PER THE SPAULDING CLASSIFICATIONS SEMICRITICAL THE CATEGORY THAT DESCRIBES MEDICAL DEVICES OR INSTRUMENTS (E.G., MOUTH MIRROR) THAT COME INTO CONTACT WITH MUCOUS MEMBRANES AND DO NOT ORDINARILY PENETRATE BODY SURFACES. THE DENTAL PROBE IS USED TO MEASURE GINGIVAL POCKET DEPTH SO THE PRODUCT DOES FALL INTO THE SEMICRITICAL CATEGORY. ASSESSMENT/RECOMMENDATION ENCOURAGE MANUFACTURER TO PROVIDE REPROCESSING INSTRUCTIONS PRIOR TO USE FOR THE D002-008-P PRODUCT. FDA SAFETY REPORT ID# (B)(4).