(b)(4).The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the biliary system during an endoscopic retrograde cholangiopancreatography (ercp) with spyglass procedure performed on (b)(6) 2019.According to the complainant, during the procedure, spybite biopsy forceps was inserted through the spyscope ds and several biopsies were performed.It was then found that the forceps would not open properly towards the end of the procedure and the working channel sleeve of the spyscope ds protruded the procedure was still completed using the same original spybite biopsy forceps and spyscope ds.There were no patient complications reported as a result of this event.
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