MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ENDOSCOPE MODEL EC-760S-V/L; COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	EC-760S-V/L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On may 28th 2024 fujifilm healthcare americas corporation was informed of an event involving ec-760s-v/l.It was reported that the distal portion of scope came completely apart at the bending section during a procedure.The staff deny any mishandling and state it happened when regularly using and turning the knobs during a procedure.There was no patient harm or injury reported.No additional information was provided.The report is being submitted in an abundance of caution.
Additional Manufacturer Narrative
Ref comp #(b)(4).

• Brand Name: FUJIFILM ENDOSCOPE MODEL EC-760S-V/L
• Common Device Name: COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 25885 38; JA 2588538
• MDR Report Key: 19618045
• Report Number: 1000513161-2024-00034
• Device Sequence Number: 17883234
• Product Code: FDF
• UDI-Device Identifier: 14547410397649
• UDI-Public: (01)14547410397649(11)200501
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: EC-760S-V/L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/28/2024
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown