The service center was informed that during preparation for use, the customer plugged in the surgical endoscopes the metal housing collar was drooping or loose and not holding the endoscopes tightly enough causing the high intensity switch to disengage.Also, causing loss of light to the cases.There was no patient injury reported.
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This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: d8, g3, g6, h2, h4, h6, and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, wearing deterioration of the scope socket allowed the scope to loosen, to come off easily, or failed to detect in long-term repeated use of the device.It has been more than 8 years since the subject device was manufactured.
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