It is reporting during reprocessing of an uretero-reno videoscope using a sterrad reprocessor and a wire/nylon bristle brush for ureteroscopes, after cleaning it several times, black residue keeps coming out of it.The was no patient contact/impact related to this occurrence.
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This report is being updated to provide investigation findings.New information is reported in h4, h6, and h10.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: inspection of the endoscopic system - inspection of the irrigation function precautions : perform a leakage test on the endoscope after each precleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Use of a leaking endoscope may also pose an infection control risk.Conclusion: the definitive cause of the reported events could not be established.Based on the available information, it is possible the internal biopsy channel was scraped forcibly with the insertion of the endo therapy accessories/cleaning brush by the user while angulating.As a result, lubricant was used during the assembly of the scope leaked from the scratches.
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