MEDPLAST MEDICAL, INC. REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number D2201 |
Device Problems
Material Fragmentation (1261); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/19/2019 |
Event Type
malfunction
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Event Description
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It was reported that during convective radiofrequency water vapor thermal therapy treatment of the prostate, while delivering the 10 th treatment, a plastic flaking off was able to be seen inside the patient.The material was flushed out of the patient's body.The procedure was completed utilizing the same device without clinical consequences to the patient.
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Manufacturer Narrative
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The returned device was disassembled and the fragmented piece was identified to come from the silicon duck bill that the scope enters through in the back of the device.This was most likely caused by the scope being pushed in with too much force or pushed in at a non-linear angle.A review of the device history record confirmed that the device met all material, assembly and performance specifications prior to release.A review of the device ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.Based on the analysis results, the information provided is not sufficient to assign a cause, therefore, the investigation conclusion code is cause not established.
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Event Description
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It was reported that during convective radiofrequency water vapor thermal therapy treatment of the prostate, while delivering the 10th treatment, a plastic flaking off was able to be seen inside the patient.The material was flushed out of the patient's body.The procedure was completed utilizing the same device without clinical consequences to the patient.
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Search Alerts/Recalls
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