BOSTON SCIENTIFIC - SPENCER SPYSCOPE DS ACCESS & DELIVERY CATHETER; CHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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Model Number M00546600 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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The lot number was not reported therefore the manufacture date and expiration date are unknown.Conference abstract: a u.S.Multi-center first human use experience using the fully disposable, digital single-operator cholangiopancreatoscope (dsocp).Presentation number: 346.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in a study of digital cholangioscopes in the evaluation of first human use of indications, interventions, and operating characteristics.According to the complainant, from (b)(6) 2015, a total of 124 cases were completed.The study found that one patient experienced mild pancreatitis, and one patient experienced cholangitis.The abstract did not provide any additional information regarding the patients involved in the study.
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Event Description
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It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in a study of digital cholangioscopes in the evaluation of first human use of indications, interventions, and operating characteristics.According to the complainant, from (b)(6) 2015, a total of 124 cases were completed.The study found that one patient experienced mild pancreatitis, and one patient experienced cholangitis.The abstract did not provide any additional information regarding the patients involved in the study.
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