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Patient 1
(B)(4). MANUFACTURING SITE EVALUATION: THE INSTRUMENTS ARE NOT AVAILABLE FOR INVESTIGATION. ONLY PHOTOS ARE AVAILABLE FOR THE INVESTIGATION. THE INSTRUMENTS WERE WASHED ONCE AND NOW SHOW CORROSION DAMAGED. ACCORDING TO THE AVAILABLE INFORMATION, THERE WERE NO NEGATIVE CONSEQUENCES FOR PATIENT. THE PHOTOS SHOWED FOUND REDDISH-BROWN CORROSION SPOTS. THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY REPOSING OR MAINTENANCE RELATED. ACCORDING TO THE QUALITY STANDARD A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. THE DISCOLORATION ARE PINPRICK-LIKE CORROSION HOLES SURROUNDED BY SPARKLING, REDDISH-BROWN OR MULTI-COLORED CORROSION SPOTS, OFTEN ASSOCIATED WITH CIRCULAR CORROSION DEPOSITS AROUND THE CORROSION HOLE. THE FOLLOWING POINTS COULD BE THE CAUSE OF THIS: EXPOSURE DUE TO HALIDE IONS. DRIED-ON ORGANIC RESIDUES. FREQUENT PITTING IS DUE TO THE USE OF LIQUIDS. BRAND NEW INSTRUMENTS ARE PARTICULARLY LAYER. A CAPA IS NOT NECESSARY.