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As per source document: "impossible to get the plastic stent out of the duoscope.3rd time.Plicature du kt porteur.Obligation to retrieve all the device and to input 2 metal stents." patient outcome: additional procedure as per cc form: "need to put two metal stent instead." patient/event info - notes: 1.Please indicate where the device was stored prior to use.In operating room.2.What is the reorder number, outer diameter and length of the wire guide that was used with this device in this procedure? na.3.Were previous procedures i.E.Sphincterotomy etc.Carried out prior to placing the device over the particular wire guide? if yes please indicate the procedure performed.Na.4.Was the wire guide inspected for damage prior to use? na.5.Was the device at the centre of the complaint inspected for damage prior to use? na.6.Did the patient involved exhibit altered anatomy or tortuous anatomy? na.7.If not with the device in question, how was the procedure finished? for complaints occurring during use (once in contact with endoscope) also ask: 1.Had a sphincterotomy been performed prior to this occurrence? yes.2.What is the endoscope manufacturer, the model number and working channel size that was used for the procedure? pentax.3.Does your medical facility have a service/maintenance schedule associated with its endoscopes? yes.4.Please indicate the location in the body where the stent device was to be placed.I.E.Biliary duct, pancreatic duct, other.Pancreatic duct.5.Was resistance encountered when advancing the wire guide to the target location? na.6.Was the stricture dilated prior to placing the device?* if so, please indicate what device(s) were used.Na.7.Was resistance encountered when advancing the introduction system in place to the target location? na.8.Was resistance encountered when advancing the stent through the obstructed area? na.(mark n/a if device was not used on any patient) after placement, was stent position verified? if yes, please describe how.9.Please estimate/indicate the amount of time the stent was in place dwelling prior to this occurrence.Na.10.Did any section of the device detach inside the endoscope or patient no 11.If the device broke upon removal, please indicate what removal tool(s) were used (manufacturer).Na.12.Please indicate any other endoscopic accessories (if any) that came into contact with the stent or introduction system during the procedure.13.Were any modifications made to the complaint device or accessories used with the device in this procedure? for example guiding catheter shortened.If so please indicate the modifications and why they were necessary.
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