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As reported to customer relations: "e-mail forwarded from customer: 'the reason for my email is in regards to a situation that i wanted to make you aware of on friday (b)(6) with one of the cook- one action delivery stent introduction (g31527).Unfortunately the packaging was discarded but i was able to get the lot number.Lot number c1816503.While in the ercp procedure, the black introducer was fed onto the wire jag wire and into the patient.Once the dr got to the duodenum the introducer was visible on camera and the staff could visibly see a metal wire from the introducer.Normally this is just a plastic sheath.The dr then had to pull out the scope from the patient as well as the introducer because of the loose metal wire.This metal wire was not loose and visible prior to being inserted in the patient.Is there any way that we could get a credit for this product? please let me know if you have any questions.'" 1.Did any unintended section of the device remain inside the patient¿s body? no ¿ if yes, please describe.2.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no ¿ if yes, please describe.3.Did the patient require any additional procedures due to this occurrence? no ¿ if yes, please describe.4.Did the product cause or contribute to the need for additional procedures? no ¿ if yes, please specify additional procedures and provide details.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no 6.Has the complainant reported that the product caused or contributed to the adverse effects? no ¿ please specify adverse effects and provide details.Additional information provided by customer on 04nov2021: "hello, my name is (b)(6).I was one of the rns in the procedure.I have answered the questions to the best of my memory.Thanks ¿ does the complaint relate to: o device placement o device removal o observation prior to patient contact ¿ what was the target location for the stent? o common bile duct ¿ please describe the storage conditions of the device prior to use especially those pertaining to temperature and light exposure.O cool, dark room ¿ what is the reorder number, diameter and length of the wire guide that was used with this device in this procedure? o 0.035inch x 260cm wire ¿ was the wire guide lubricated prior to use? n/a, yes, no ¿ was the wire guide inspected for damage prior to use? n/a, yes, no ¿ was the device at the center of the complaint inspected for damage prior to use? n/a, yes, no ¿ were previous procedures i.E.Sphincterotomy etc.Carried out prior to placing the complaint device? n/a, yes-sphincterotomy, no o if yes, please indicate the procedure performed.¿ did the patient involved exhibit altered anatomy or tortuous anatomy? n/a, yes, no ¿ if not with the device in question, how was the procedure finished? an additional stent introducer was used ¿ were any other defects observed on the device prior to return (other than the reported complaint issue? yes, no o if yes, please detail any other defects observed.¿ what is the endoscope manufacturer, the model number and working channel size that was used for the procedure? not sure ¿ does the medical facility have a service/maintenance schedule associated with its endoscopes? n/a, yes, no ¿ please indicate the location in the body where the stent device was to be placed.I.E.Biliary duct, pancreatic duct, other.O if other, please specify.Common bile duct ¿ was resistance encountered when advancing the wire guide to the target location? n/a, yes, no ¿ was resistance encountered when advancing the introduction system in place to the target location? n/a, yes, no ¿ how did the physician deal with this resistance? attempt to push the introducer harder ¿ how did the physician determine the length of the stent to be used for the procedure? based on xray image ¿ where was the stricture located in the duct? too long ago to recall ¿ was the stricture dilated prior to placing the device? no o if so, please indicate what device(s) were used.¿ was resistance encountered when advancing the stent through the obstructed area? n/a, yes, no ¿ after placement, was stent position verified? n/a, yes, no o if yes, please describe how.Visual evidence of bile flow and x-ray image ¿ please estimate the amount of time the stent was in place prior to this occurrence.¿ please indicate whether the device broke in the endoscope or in the patient.N/a, endoscope, patient ¿ please indicate what tools were used during retrieval (e.G.Basket, balloon, snare, forceps etc.): the introducer was pulled out of the patient without tools ¿ were any modifications made to the complaint device or accessories used with the device in this procedure? (e.G.Guiding catheter shortened, stent cut etc.) n/a, yes, no o if yes, please indicate what modifications were made.¿ please indicate why the modifications were necessary.¿ please indicate any other endoscopic accessories (if any) that came into contact with the stent or introduction system during the procedure.¿ were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no o if yes, please specify what was observed and where on the device it was observed."--did (b)(6) 2021.2.1 for all complaints, ask: 2.1.1 does the complaint relate to: ¿ device placement ¿ device removal ¿ observation prior to patient contact 2.1.2 what was the target location for the stent? 2.1.3 please describe the storage conditions of the device prior to use especially those pertaining to temperature and light exposure.2.1.4 *what is the reorder number, diameter and length of the wire guide that was used with this device in this procedure?* 2.1.5 was the wire guide lubricated prior to use? n/a, yes, no 2.1.6 *was the wire guide inspected for damage prior to use? n/a, yes, no* 2.1.7 was the device at the center of the complaint inspected for damage prior to use? n/a, yes, no 2.1.8 were previous procedures i.E.Sphincterotomy etc.Carried out prior to placing the complaint device? n/a, yes, no ¿ if yes, please indicate the procedure performed.2.1.9 did the patient involved exhibit altered anatomy or tortuous anatomy? n/a, yes, no 2.1.10 * if not with the device in question, how was the procedure finished?* 2.1.13 were any other defects observed on the device prior to return (other than the reported complaint issue? yes, no ¿ if yes, please detail any other defects observed.2.2 for complaints occurring during use (once in contact with endoscope) also ask: 2.2.1 had a sphincterotomy been performed prior to this occurrence? n/a, yes, no 2.2.2 what is the endoscope manufacturer, the model number and working channel size that was used for the procedure? 2.2.3 does your medical facility have a service/maintenance schedule associated with its endoscopes? n/a, yes, no 2.2.4 please indicate the location in the body where the stent device was to be placed.I.E.Biliary duct, pancreatic duct, other.¿ if other, please specify.2.2.5 *was resistance encountered when advancing the wire guide to the target location? n/a, yes, no * 2.2.6 *was resistance encountered when advancing the introduction system in place to the target location? n/a, yes, no * ¿ how did the physician deal with this resistance? 2.2.7 how did the physician determine the length of the stent to be used for the procedure? 2.2.8 where was the stricture located in the duct? 2.2.9 *was the stricture dilated prior to placing the device?* ¿ if so, please indicate what device(s) were used.2.2.10 *was resistance encountered when advancing the stent through the obstructed area? n/a, yes, no * 2.2.11 after placement, was stent position verified? n/a, yes, no ¿ if yes, please describe how.2.2.12 please estimate the amount of time the stent was in place prior to this occurrence.2.2.14 please indicate whether the device broke in the endoscope or in the patient.N/a, endoscope, patient ¿ if yes, please indicate what tools were used during retrieval (e.G.Basket, balloon, snare, forceps etc.): 2.2.16 were any modifications made to the complaint device or accessories used with the device in this procedure? (e.G.Guiding catheter shortened, stent cut etc.) n/a, yes, no ¿ if yes, please indicate what modifications were made: 2.2.17 please indicate why the modifications were necessary.2.2.18 please indicate any other endoscopic accessories (if any) that came into contact with the stent or introduction system during the procedure.2.2.22 were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no ¿ if yes, please specify what was observed and where on the device it was observed.
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