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
|
(b)(4).
|
|
Event Description
|
On 14 aug 2019 fujifilm medical systems u.S.A., inc was informed by fujifilm corporation 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: on (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 14 aug 2019 fujifilm medical systems u.S.A., inc was informed by fujifilm corporation 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: on (b)(6) 2019 at 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
|
Ref: internal complaint number (b)(4).Patient weight, ethnicity and race: unknown.Initial reporter information: unknown.Fujifilm corporation completed the investigation on 11 sep 2019, fujifilm medical systems u.S.A., inc was notified of additional information on 23 sep 2019.
|
|
Search Alerts/Recalls
|
|