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to Insert）、部品の脱落（Detachment of Device or Device Component）、破損（Break）が挙げられています。回収報告は確認されていません。",{"pma":621,"k510":622,"as_of":624,"events":625,"recalls":628,"top_problems":630},{"latest":93,"originals":92,"supplements":92},{"total":94,"last5y":92,"latest":623,"applicants":333},"2017-09-14","2026-08",{"death":453,"other":499,"total":95,"injury":337,"last5y":333,"malfunction":626,"latest_month":627},65,"2026-01",{"total":92,"last5y":92,"latest":93,"class_i":92,"class_ii":92,"class_iii":92,"top_root_causes":629},[],[631,632,633],"Difficult to Insert","Detachment of Device or Device Component","Break","4ff19bee85ae9b15101a682efa97c52c63e76024e4c6b79e2fb305f9c203fa77","2026-08-24T04:21:40.396908+00:00",{"items":637,"total":92},[],{"items":639,"total":94},[640,646,650,656,660,664,669,673,677,681,685,689,693,696,700],{"k_number":30,"device_name":641,"applicant":642,"decision_date":623,"clearance_type":643,"decision_code":644,"statement_or_summary":645},"Veress Needle","Wickimed (Huizhou) 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Co.","1996-08-05",{"k_number":22,"device_name":665,"applicant":666,"decision_date":667,"clearance_type":643,"decision_code":668,"statement_or_summary":655},"ACCESS EXPANSION SYSTEM","Micro-Medical Devices, Inc.","1995-06-15","SESK",{"k_number":19,"device_name":670,"applicant":671,"decision_date":672,"clearance_type":643,"decision_code":644,"statement_or_summary":645},"ELMED PNEUMOPERITONEUM NEEDLES","Henke-Sass, Wolf GmbH","1994-08-10",{"k_number":18,"device_name":674,"applicant":675,"decision_date":676,"clearance_type":643,"decision_code":644,"statement_or_summary":655},"VERRES NEEDLE","Linvatec Corp.","1994-06-24",{"k_number":21,"device_name":678,"applicant":679,"decision_date":680,"clearance_type":643,"decision_code":644,"statement_or_summary":645},"NEEDLE, PNEUMOPERITONEUM, SPRING LOADED","Ranfac, Corp.","1993-07-23",{"k_number":26,"device_name":682,"applicant":683,"decision_date":684,"clearance_type":643,"decision_code":644,"statement_or_summary":655},"CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE","Clarus Medical Systems, Inc.","1992-11-16",{"k_number":31,"device_name":686,"applicant":687,"decision_date":688,"clearance_type":643,"decision_code":644,"statement_or_summary":655},"ENTREE NEEDLE","Core Dynamics, Inc.","1991-11-27",{"k_number":24,"device_name":690,"applicant":691,"decision_date":692,"clearance_type":643,"decision_code":644,"statement_or_summary":655},"ORIGINEEDLE, MODIFICATION","Origin Medsystems, Inc.","1991-11-08",{"k_number":32,"device_name":694,"applicant":691,"decision_date":695,"clearance_type":643,"decision_code":644,"statement_or_summary":93},"ORIGINEEDLE(TM)","1991-03-29",{"k_number":20,"device_name":697,"applicant":698,"decision_date":699,"clearance_type":643,"decision_code":644,"statement_or_summary":93},"DISPOSABLE PNEUMOPERITONEUM NEEDLE","United States Surgical, A Division of Tyco Healthc","1986-10-02",{"k_number":27,"device_name":701,"applicant":702,"decision_date":703,"clearance_type":643,"decision_code":644,"statement_or_summary":93},"ENDONEEDLE","Endotherapeutics","1985-01-09",{"items":705,"total":92},[]]