MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM 600 SERIES ENDOSCOPE EG-600WR; FUJIFILM VIDEO ENDOSCOPE

Model Number EG-600WR

Device Problems Mechanical Jam (2983); Insufficient Information (3190)

Patient Problem Abrasion (1689)

Event Date 08/05/2019

Event Type  Injury  

Manufacturer Narrative

Weight: unknown.Ethnicity:unknown.Race: unknown.Name and address: unknown.Occupation: unknown.Cause investigation: fujifilm requested the endoscope in question to be returned to (b)(4) for investigation.If any additional relevant information is provided, a supplemental report will be submitted.

Event Description

On (b)(6) 2019 fujifilm was informed that a patient in a south korean hospital presented with a mucosal injury post procedure with a fujifilm endoscope.This occurred due to the bending section of the endoscope becoming stuck in an upward bent position and causing mucosal bleeding during removal.Timeline: (b)(6) 2019 approximately 16:00: endoscopy procedure started.Approximately 90 seconds after the start of the procedure: when the bending section of the endoscope was bent upward to the maximum, the up/down angle dial (the dial that makes the bending section bend upward and downward) ceased to move, leaving the bending section in the bent state.The user tried to release the bend by inserting forceps into the forceps channel without success.About 18 minutes after the start of the procedure: the user inserted another endoscope through which a snare was placed to pull the bent section and reduce the bending angle.After that, the first endoscope was successfully removed.However, while doing so, bleeding occurred from the mucous membrane.About 33 minutes after the start of the procedure: endoscopic procedure was completed.Admission and additional examination were recommended to the patient, but the patient refused and moved to another hospital.Around 21:00: because another hospital refused to accept the patient, the patient returned to this hospital and was admitted.The patient complained of stomach upset.Patient situation: after hospitalization, ct images were taken and the patient is being monitored.Cause investigation: fujifilm requested the endoscope in question to be returned to (b)(4) for investigation.There was no death associated with this event; this report is being submitted in abundance of caution.

Event Description

On 06 aug 2019 fujifilm was informed that a patient in a (b)(6) hospital presented with a mucosal injury post procedure with a fujifilm endoscope.This occurred due to the bending section of the endoscope becoming stuck in an upward bent position and causing mucosal bleeding during removal.Timeline: 05 aug 2019 approximately 16:00: endoscopy procedure started.Approximately 90 seconds after the start of the procedure: when the bending section of the endoscope was bent upward to the maximum, the up/down angle dial (the dial that makes the bending section bend upward and downward) ceased to move, leaving the bending section in the bent state.The user tried to release the bend by inserting forceps into the forceps channel without success.About 18 minutes after the start of the procedure: the user inserted another endoscope through which a snare was placed to pull the bent section and reduce the bending angle.After that, the first endoscope was successfully removed.However, while doing so, bleeding occurred from the mucous membrane.About 33 minutes after the start of the procedure: endoscopic procedure was completed.Admission and additional examination were recommended to the patient, but the patient refused and moved to another hospital.Around 21:00: because another hospital refused to accept the patient, the patient returned to this hospital and was admitted.The patient complained of stomach upset.Patient situation: after hospitalization, ct images were taken and the patient is being monitored.Cause investigation: fujifilm requested the endoscope in question to be returned to japan for investigation.There was no death associated with this event; this report is being submitted in abundance of caution.

Manufacturer Narrative

Patient demographics: unknown.Initial reporter information: unknown.Cause investigation summary: on 11 sep 2019 fujifilm corporation completed the investigation of subject scope and determined that the possible cause is related to repair/manufacturing.Fujifilm found an extra unsecured screw and traces of screw rubbing in the bending mechanism.It was determined that the operator left unnecessary screws in the scope.It was confirmed that the failure was reproduced when the screw was inserted into the bending mechanism.This defect is the first event and is considered extremely rare.If any additional relevant information is provided, a supplemental report will be submitted.

• Brand Name: FUJIFILM 600 SERIES ENDOSCOPE EG-600WR
• Type of Device: FUJIFILM VIDEO ENDOSCOPE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun; kanagawa, 00258 8538; JA 002588538
• MDR Report Key: 8947190
• MDR Text Key: 161057765
• Report Number: 3001722928-2019-00010
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• PMA/PMN Number: K132210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-600WR
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 08/06/2019
• Supplement Dates FDA Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 26 YR