MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DUODENOSCOPE; ENDOSCOPE

Model Number	ED-580T
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: unknown.The model ed-580t does not have a 510(k) in the us, but the product is similar to ed-580xt initial reporter information was not disclosed.510(k) used is for ed-580xt.Doctor's opinion: a patient under ercp is sedated and unconscious, and if the distal cap falls into the oral cavity, it might cause aspiration and suffocate the patient.If the distal cap enters the trachea and the patient coughs, the distal cap might come out.However, a possibility, even though it is low, of causing death cannot be completely denied.Investigation of the subject ed-580t: the device was not returned to fujifilm because fujifilm performed an evaluation on-site.The tip of ed-580t was examined.However, no abnormality that could have led to the failure (distal cap drop) was found.The user discarded the concerned distal cap, so it could not be examined.Examination of the non-fujifilm mouthpiece used: the mouthpiece concerned was already discarded, and the actual product could not be investigated.Fujifilm examined a new mouthpiece, and a part of the ridge line of the inner diameter of the mouthpiece was found not rounded.Cause of distal cap drop failure: the distal cap is a single-use product that is attached and removed each time.When the distal cap is attached to the endoscope, there is a slight gap between the distal cap and the endoscope.It has been concluded that the ridgeline of the mouthpiece was caught by this gap, which made the distal cap come off and fall into the oral cavity.As a result of additional investigation, it was found that the cap would fall off when the cap was not installed properly.If the cap is properly connected, it cannot be removed.If any additional relevant information is provided, a supplemental report will be submitted.
Event or Problem Description
On (b)(6) 2019 fujifilm corporation was informed by a customer in (b)(6) that a distal end cap prematurely detached from the distal end of a duodenoscope during a procedure.The distal cap was attached to the distal end of the duodenoscope ed-580t, and an endoscopic retrograde cholangiopancreatography (ercp) was performed.During removal of the endoscope at the end of the procedure, it was noticed that the distal cap was missing.The patient was in a prone position and the face was slanted, and the mouthpiece was slightly out of position.During removal, the user felt that the endoscope was caught on the mouthpiece.An upper gastrointestinal scope was inserted to observe the inside of the gastrointestinal tract to locate the distal cap; however, the distal cap was not found.Then the laryngoscope was reinserted, the distal cap was found and retrieved.No health hazard occurred.There was no death or serious injury associated with this event.This report is being submitted in abundance of caution.
Additional Manufacturer Narrative
Date of birth - unknown.The model ed-580t does not have a 510(k) in the us, but the product is similar to ed-580xt initial reporter information was not disclosed.510(k) used is for ed-580xt.Doctor's opinion: a patient under ercp is sedated and unconscious, and if the distal cap falls into the oral cavity, it might cause aspiration and suffocate the patient.If the distal cap enters the trachea and the patient coughs, the distal cap might come out.However, a possibility, even though it is low, of causing death cannot be completely denied.Investigation of the subject ed-580t: the device was not returned to fujifilm because fujifilm performed an evaluation on-site.The tip of ed-580t was examined.However, no abnormality that could have led to the failure (distal cap drop) was found.The user discarded the concerned distal cap, so it could not be examined.Examination of the non-fujifilm mouthpiece used: the mouthpiece concerned was already discarded, and the actual product could not be investigated.Fujifilm examined a new mouthpiece, and a part of the ridge line of the inner diameter of the mouthpiece was found not rounded.Cause of distal cap drop failure: the distal cap is a single-use product that is attached and removed each time.When the distal cap is attached to the endoscope, there is a slight gap between the distal cap and the endoscope.It has been concluded that the ridgeline of the mouthpiece was caught by this gap, which made the distal cap come off and fall into the oral cavity.As a result of additional investigation, it was found that the cap would fall off when the cap was not installed properly.If the cap is properly connected, it cannot be removed.If any additional relevant information is provided, a supplemental report will be submitted.On 26 feb 2020 the fda requested that fujifilm corporation submit a follow up report to correct the device problem code.Correction: clarified event description to indicate that the cap was located in the patient's oral cavity (b)(4).If any additional relevant information is provided, a supplemental report will be submitted.
Event or Problem Description
On 06 dec 2019 fujifilm corporation was informed by a customer in (b)(6) that a distal end cap prematurely detached from the distal end of a duodenoscope during a procedure.The distal cap was attached to the distal end of the duodenoscope ed-580t, and an endoscopic retrograde cholangiopancreatography (ercp) was performed.During removal of the endoscope at the end of the procedure, it was noticed that the distal cap was missing.The patient was in a prone position and the face was slanted, and the mouthpiece was slightly out of position.During removal, the user felt that the endoscope was caught on the mouthpiece.An upper gastrointestinal scope was inserted to observe the inside of the gastrointestinal tract to locate the distal cap; however, the distal cap was not found.Then the laryngoscope was reinserted, the distal cap was found in the patient's oral cavity and retrieved.No health hazard occurred.There was no death or serious injury associated with this event.This report is being submitted in abundance of caution.

• Brand Name: FUJIFILM DUODENOSCOPE
• Common Device Name: ENDOSCOPE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun; kanagawa, 00258 8538; JA 002588538
• MDR Report Key: 9516562
• Report Number: 3001722928-2019-00017
• Device Sequence Number: 533407
• Product Code: FDT
• UDI-Device Identifier: 04547410330649
• UDI-Public: (01)04547410330649
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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
• Operator of Device: Health Professional
• Device Model Number: ED-580T
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 57