This report is being supplemented to provide additional information received from the user facility and the results of the legal manufacturer's final investigation.The following sections were updated: b5, d8, e2, e3, g3, g6, h2, h4, h6 and h10.Probable causes for a cracked lid include: the lid contacting with a scope when it was closed and/or an external impact to the lid.The device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Design of the device or manufacturing cannot be confirmed as factors to cause the event.Per the instructions for use (ifu): "before using the equipment, always check that there is no irregularity regarding the following points on the lid and the lid packing.If there is any irregularity, cleaning fluid or disinfectant solution may leak out.The lid is not cracked, broken, or otherwise damaged." the most probable cause for the reported event is user handling.
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Additional information was provided by the contact at the user facility: the crack was internal so no water came through, no leaking.There were no patient infections or scopes with positive cultures as a result of the cracked lid.The detergent is checked every use and the user watches the marker/indicator to make sure when to change it.The reprocessor is inspected before use, throughout the day, in-between cycles and again at the end of the day to make sure that it is ready for the next day.The lid was replaced and the unit is back in service and in working order.
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