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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DUODENOSCOPE; ENDOSCOPE

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FUJIFILM CORPORATION FUJIFILM DUODENOSCOPE; ENDOSCOPE Back to Search Results
Model Number ED-580XT
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2020
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
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.
 
Manufacturer Narrative
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.
 
Event Description
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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Brand Name
FUJIFILM DUODENOSCOPE
Type of Device
ENDOSCOPE
Manufacturer (Section D)
FUJIFILM CORPORATION
798 miyanodai kaisei-machi
ashigarakami-gun
kanagawa, 00258 8538
JA  002588538
MDR Report Key9820185
MDR Text Key227200114
Report Number3001722928-2020-00007
Device Sequence Number1
Product Code FDT
UDI-Device Identifier14547410359289
UDI-Public(01)14547410359289
Combination Product (y/n)N
PMA/PMN Number
K191747
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberED-580XT
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/26/2020
Initial Date FDA Received03/11/2020
Supplement Dates Manufacturer Received02/26/2020
Supplement Dates FDA Received03/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
CONMED SCOPE SAVER BITEBLOCK (MOUTHPIECE).; CONMED SCOPE SAVER BITEBLOCK (MOUTHPIECE).; EXTRACTION BALLOON MULLTI-3V, COOK.; EXTRACTION BALLOON MULLTI-3V, COOK.; JAGWIRE ANGLE TIP .035, BSCI.; JAGWIRE ANGLE TIP .035, BSCI.; JAGWIRE GUIDEWIRE .035, BSCI.; JAGWIRE GUIDEWIRE .035, BSCI.; SNARE 11MM, BSCI.; SNARE 11MM, BSCI.; SPYGLASS EHL FIBER, BSCI.; SPYGLASS EHL FIBER, BSCI.; SPYGLASS, BSCI.; SPYGLASS, BSCI.; TRAPEZOID STONE BASKET, BSCI.; TRAPEZOID STONE BASKET, BSCI.
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient Weight104
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