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Catalog Number ECHO-19 |
Device Problem
Off-Label Use (1494)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/17/2021 |
Event Type
malfunction
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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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When dr.(b)(6), the metal leur lock was separated without being fixed to the scope.The nurse tried to fix it again, but it was not fixed.Dr.(b)(6) used another 19g.Device used for eus guided pseudocyst drainage, from stomach to pseudocyst - off label use.Did any section of the device remain inside the patient body? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedure(s)? no.Were there any adverse effects on the patient due to this occurrence? no.Did the product cause or contribute to the adverse effect(s)? no.
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Manufacturer Narrative
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Device evaluation: the echo-19 device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Document review including ifu review prior to distribution, all echo-19 devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the lot numbers are unknown a review of manufacturing records could not be performed.The notes section of the instructions for use, ifu0101 which accompanies 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".There is evidence to suggest that the customer did not follow the instructions for use as the device was used for drainage (ifu0101).Root cause review: a definitive root cause for the customer complaint could be attributed to off-label, as the device was used for drainage and as per ifu101 "this device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope." summary: complaint is confirmed based on the customer's testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
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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 on the 16-jun-2022.
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Search Alerts/Recalls
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