Customer reported that during a procedure the scope was unable to insufflate the patient's stomach.The procedure had been aborted.This event occurred at the time of during during use.There was no report of patient harm.This event meets the requirements for fda reportability; however submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.
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B4: date of this report h2: if follow-up, what type? h3:device evaluated by manufacture h6: coding changed based on the investigation result.D4:unique identifier (udi) h4:device manufacture date.Evaluation summary: pentax medical pai performed good faith efforts to gather additional information regarding this event and provided an email response on 24-feb-2024 for the following questions.Q1.Was the procedure for treatment or diagnostic purposes? a: diagnostic q2.Was the patient recalled for further screening? a: unknown q3.What is the current status of the patient.A: unknown q4.Was the product removed from circulation immediately after the failure/event occurred and subsequently called in for service/replacement? a:yes q5.Device current location and status? a: at facility.The endoscope will be sent in for repair.Based on the investigation, it was determined that the scope's air feeding tube had buckled due to repeated angulation, but it could not be determined.A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured pentax medical miyagi on 11-may-2021 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed on 11-may-2021.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.
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