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Device Interaction Problem（患者・機器間相互作用の問題）、Fracture（破損）、Material Integrity Problem（材料の完全性の問題）が挙げられています。回収については累計件数の報告は確認されていません。",{"pma":142,"k510":143,"as_of":146,"events":147,"recalls":151,"top_problems":153},{"latest":36,"originals":35,"supplements":35},{"total":37,"last5y":144,"latest":145,"applicants":37},1,"2025-09-10","2026-08",{"death":37,"other":35,"total":38,"injury":148,"last5y":149,"malfunction":37,"latest_month":150},7,10,"2026-05",{"total":35,"last5y":35,"latest":36,"class_i":35,"class_ii":35,"class_iii":35,"top_root_causes":152},[],[154,155,156],"Patient Device Interaction Problem","Fracture","Material Integrity Problem","8dae8d43b6e8d4f7ae886f2eeee8b99b6522564555836f8b7c698710db6dc20c","2026-08-24T05:16:12.270965+00:00",{"items":160,"total":35},[],{"items":162,"total":37},[163,169],{"k_number":18,"device_name":164,"applicant":165,"decision_date":145,"clearance_type":166,"decision_code":167,"statement_or_summary":168},"Surfacer Inside-Out Access Catheter System","Merit 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