This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 investigation, the root cause could not be determined.In regards to the foreign material, it could not be identified and the cause of the material remaining in the device could not be specified.There was no damage to the area where the foreign material was detected and it was confirmed that reprocessing was performed according to the instructions for use (ifu).In regards to the cracked distal end, it is likely physical stress was applied to the distal end while the user was handling the device, which resulted in the reported event.The reported issue regarding foreign material can be detected by handling the device in accordance with the following ifu: operation manual_ inspection of the endoscope_ inspection of the endoscopic system preparation and inspection the reported issue regarding the cracked distal end can be detected and prevented by handling the device in accordance with the following ifu: operation manual_ preparation and inspection_ inspection of the endoscope inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.Operation manual_ important information ¿ please read before use_ warnings and cautions warning: do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation.It could also cause parts of the endoscope to fall off inside the patient.Olympus will continue to monitor field performance for this device.
|