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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM GASTROSCOPE MODEL EG-760R; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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FUJIFILM CORPORATION FUJIFILM GASTROSCOPE MODEL EG-760R; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number EG-760R
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
On september 22nd, 2023, fujifilm healthcare americas corporation was informed of an event involving eg-760r.It was reported that during a diagnostic procedure, the co2-would not insufflate.There was an 8-minutes delay to switch scopes.There was no harm or injury to the patient.No additional information was provided.
 
Manufacturer Narrative
Ref comp (b)(4).The fujifilm engineer has verified customers complaint with unble co2 insuflate.The engineer has tried replacing the tubing buttons, and found debris underneath the nozzle causing a/w flow blockage.It was recommended that the nozzle needs to be replace due to clogg.
 
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Brand Name
FUJIFILM GASTROSCOPE MODEL EG-760R
Type of Device
GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
FUJIFILM CORPORATION
798 miyanodai kaisei-machi
ashigarakami-gun, kanagawa 258-8 538
JA  258-8538
MDR Report Key18455364
MDR Text Key332387487
Report Number1000513161-2024-00003
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberEG-760R
Device Catalogue NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/22/2023
Event Location Hospital
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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