COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE; KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
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Catalog Number UNKNOWN |
Device Problem
Off-Label Use (1494)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 07/16/2020 |
Event Type
malfunction
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Event Description
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Debourdeau et al 2020 (duette) ¿ ¿antireflux mucosectomy band (arm-b) in treatment of refractory gastroesophageal reflux disease after bariatric surgery¿.Arm-b procedures were performed under general anesthesia with tracheal intubation.Patients were placed in a supine posi-tion.A large operating channel endoscope (3.8 mm) was used for the procedure (fujinon, tokyo, japan or pentax, tokyo, japan), with a multi-band ligation device (duette, cook medical, winston salem, usa) placed at the tip of an endo-scope.The endoscope was positioned at the level of egj within the axis of the lesser curve.Then, the procedure was as follows: a 23-g needle was used to inject in the submucosa adren-aline serum (1/1000) for mucosal lifting.The egj mucosa was captured with band ligation (1 cm in the esophagus and 2 cm in the stomach).The captured mucosa was cut with a hexagonal snare (duette, cook medical, winston salem, nc, usa).The electrosurgical unit setting was endocut q, effect 2 (erbe, erlangen, germany).These three steps were repeated until completion of a piece-meal mucosectomy of three-quarters of the circumference, involving predominantly the gastric side of the eg junction.One patient had upper gi bleeding with 2 g/dl of hemoglobin loss managed conservatively with iron perfusion and ppis.This file will capture the potential that this event occurred in belgium, pr 327094 will capture the potential that this event occurred in france.Off label use confirmed on 01-oct-21 - used for arms procedure.One patient had upper gi bleeding with 2 g/dl of hemoglobin loss managed conservatively with iron perfusion and ppis.
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Manufacturer Narrative
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Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.
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Manufacturer Narrative
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Device evaluation: the duette devices of unknown lot numbers involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.As the rpn and lot number is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution dt devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The instructions for use possible for this device, ifu0026-10 which would accompany this device instructs the user to ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ it should be noted that the device was used off-label, outside its intended use stated in the instructions for use ifu0026-10 ¿for endoscopic mucosal resection in the upper gi tract¿ "do not use this device for any purpose other than stated intended use.¿ 6 patients were involved in this study and according to the information received duette multi-band mucosectomy device was used throughout the study to treat gerd.This is regarded as off label use as the device was used in arms procedure.A definitive root cause can be attributed to the off-label use of the device, when the device is outside its stated intended use it may lead to outcomes that were never intended to happen and were never studied.Where the arms procedure use of the device is not a stated use as per the ifu and therefore has not being tested in a clinical setting.Summary: complaint is confirmed based on customer testimony.According to the initial reporter, one patient had upper gi bleeding with 2g'dl of hemoglobin loss managed conservatively with iron perfusion and ppis complaints of this nature will continue to be monitored for potential emerging trends.
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