Model Number ED-580XT |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical devices: mouthpiece reference catalog number is 000429.The distal end cap (lot # 1910) was not located therefore it is not available for evaluation, however the scope was requested for evaluation.If any additional relevant information is provided, a supplemental report will be submitted.
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Event Description
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On 26 feb 2020 fujifilm corporation was informed by the united states food and drug administration that a voluntary event report (mw5093099) had been submitted by a fujifilm customer stating that a fujifilm distal end cap (model dc-07d), used with a fujifilm duodenoscope, was discovered to be missing after a patient procedure.Upon investigation, the customer stated that the patient underwent a endoscopic retrograde cholangio-pancreatography (ercp) procedure, a treatment procedure for common bile duct stones; the procedure was successfully completed.The distal end cap was discovered to be missing after the scope was removed from the patient, during preparation for bedside cleaning.When initiating the first step of bedside cleaning "remove distal end cap", it was noted that the cap was not in place.The nurse thought that maybe the distal end cap was not on the scope to start the procedure.After confirming with additional staff that the distal end cap was indeed on the scope before and during the procedure, it was acknowledged that the distal end cap had fallen off at some point.The patient was discharged the same day as the procedure - without any adverse effects.The customer stated that the scope and the distal end cap were tested prior to the patient procedure.The customer stated that this was the first time that the distal end cap was used and it was tested twice.The following day the medical staff requested that the patient come back for an abdominal x-ray in an attempt to locate the distal end cap.There was no evidence of the distal end cap on the x-ray.The surgical suite was also checked and the distal end cap was not located.The physician indicated that the patient could have already "passed" the distal end cap.There was no injury or death associated with this event.This report is being submitted in an abundance of caution.
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Manufacturer Narrative
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Supplemental report #1.Report date: march 31, 2020.Updated information is being provided in sections h6 (method, results and conclusion codes) and h10 (narrative).The endoscope was returned to fujifilm medical systems u.S.A., inc (fmsu) on march 19, 2020, and the inspection was concluded on march 23, 2020.The results of the inspection did not reveal any abnormality that could have led to the failure of distal cap becoming detached.The distal cap was not available for inspection, therefore attachment and detachment testing was performed with a test cap.There were no issues found during inspection with the test cap.The inspection confirmed that the distal end cap attached and detached properly, and was secure after attachment.A definitive cause for the detachment could not be determined.The scope will be serviced according to device specifications and returned for clinical use.If any additional relevant information is provided, a supplemental report will be submitted.
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Event Description
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On 26 feb 2020 fujifilm corporation was informed by the united states food and drug administration that a voluntary event report (mw5093099) had been submitted by a fujifilm customer stating that a fujifilm distal end cap (model dc-07d), used with a fujifilm duodenoscope, was discovered to be missing after a patient procedure.Upon investigation, the customer stated that the patient underwent a endoscopic retrograde cholangio-pancreatography (ercp) procedure, a treatment procedure for common bile duct stones; the procedure was successfully completed.The distal end cap was discovered to be missing after the scope was removed from the patient, during preparation for bedside cleaning.When initiating the first step of bedside cleaning "remove distal end cap", it was noted that the cap was not in place.The nurse thought that maybe the distal end cap was not on the scope to start the procedure.After confirming with additional staff that the distal end cap was indeed on the scope before and during the procedure, it was acknowledged that the distal end cap had fallen off at some point.The patient was discharged the same day as the procedure - without any adverse effects.The customer stated that the scope and the distal end cap were tested prior to the patient procedure.The customer stated that this was the first time that the distal end cap was used and it was tested twice.The following day the medical staff requested that the patient come back for an abdominal x-ray in an attempt to locate the distal end cap.There was no evidence of the distal end cap on the x-ray.The surgical suite was also checked and the distal end cap was not located.The physician indicated that the patient could have already "passed" the distal end cap.There was no injury or death associated with this event.This report is being submitted in an abundance of caution.
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Search Alerts/Recalls
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