The device was returned to olympus for evaluation and repair.The evaluation could not reproduce or confirm the user report of air leakage/unable to insufflate.However, the evaluation found the forceps cover glue peeling, the rubber glue on the distal sheath cracked, and a broken element in the ultrasound image.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
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It was reported that an evis exera ii ultrasound gastrovideoscope was having air flow issues.Per the customer report, the "air button leak(ed), not insufflating." as reported, there was no patient harm or impact to patient care due to this event.
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This supplemental report is being submitted to provide the results of the manufacturer's investigation.As part of this investigation a review of the device history record (dhr) and a review of the instructions for use (ifu) were conducted.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The root cause was not established.Possible causes of the identified damage include external forces leading to peeling and damaging the distal end tip as well as aging due to the product being 2 years and 9 months old.The following statements are included in the ifu: "chapter 3 preparation and inspection: 3.2 inspection of the endoscope.Inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities." olympus will continue to monitor the field performance of this device.
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