MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM VIDEO ENDOSCOPE EC-600LS; COLONOSCOPE AND ACCESSORIES

Model Number	EC-600LS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, fujifilm healthcare americas corporation was informed of an event involving with ec-600ls.It was reported that the knob broke during the procedure prior to reaching cecum and the knob was unable to rotate.There was a delay to switch to a different scope.There was no injury to the patient reported.As such, this report is being submitted in an abundance of caution.
Additional Manufacturer Narrative
Customer comment of "broken knob" is confirmed with bsa up wire is broken, dwa drum wires frayed, isa peeling, ang loose/off.

• Brand Name: FUJIFILM VIDEO ENDOSCOPE EC-600LS
• Common Device Name: COLONOSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodia kaisei-machi; ashigarakami-gun; kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 18139948
• Report Number: 1000513161-2023-00076
• Device Sequence Number: 20438242
• Product Code: FDF
• UDI-Device Identifier: 04547410330229
• UDI-Public: (01)04547410330229(11)170501
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: EC-600LS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/17/2023
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown