As part of our investigation into this report, olympus dispatched an endoscopy support specialist (ess) and field service engineer (fse) to the facility to observe their reprocessing practices and further evaluate the oer-pro.Fse visited the facility on 4/20/2016 and performed system diagnostics for the oer-pro, but no anomalies were identified during the evaluation.The facility was informed of the oer-pro onsite evaluation results.Ess visited the facility on 4/25/2016.No deviations were immediately observed when scopes were placed in the oer-pro.However, the facility was informed of the importance of diligent leak testing and not leaving the oer-pro connectors in the systems that are not connected to scopes and being used.The facility was reminded of the importance of testing the chemical cleaning agent (acecide) before every cycle.The scope was returned to olympus for evaluation.Yellow colored debris and a stain were found at the distal end of the scope after passing a brush through the biopsy channel.No restrictions were noted when passing a brush through the biopsy channel.Visual examination of the biopsy and suction channels with an olympus borescope found scrapes and yellow stains in the biopsy channel wall at the bending section area, approximately 25 mm from the distal end.No stains or scratches were observed inside the suction channel wall.The scope also passed leak and pressure testing performed.The scope was sold on 12/09/2015 and has accumulated 55 uses.Based on the condition of the biopsy channel, the most likely cause is due to improper reprocessing and insufficient rinsing/flushing of the channels.The scope was returned to the facility unrepaired as per the customer's request.The facility requested olympus to assist with forwarding the scope to an independent microbiology laboratory for bioburden testing, per the customer's request.
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This supplemental report provides microbiology testing results, device re-evaluation and additional updates.The microbiology testing found the scope tested positive for staphylococcus hominis (gram positive cocci).The device was returned to olympus for re-evaluation.Visual examination of the biopsy channel with an olympus boroscope confirm scrapes and brown stains on the channel walls.The evaluation performed in april 2016 found foreign debris inside the suction channel.When the suction channel was re-examined, no signs of foreign material or stains were observed.No visual signs of foreign material were found at the distal end cover, nozzle, light guide lens, objective lens, bending section cover glue, or insertion tube.The scope again passed leak and pressure tests.No other abnormalities were identified during the re-evaluation.
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