MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM VIDEO ENDOSCOPE EC-760P-V/L; COLONOSCOPE AND ACCESSORIES

Model Number EC-760P-V/L

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

On september 25th 2023, fujifilm healthcare americas corporation was informed of an event involving ec-760p-v/l.It was reported that during a diagnostic for colon procedure there was no peripheral vision and decrease lighting.Their procedure took longer to finish.Due to unknown status of patient and equipment, the report is submitted with abundance of caution.There was no injury to the patient reported.

• Brand Name: FUJIFILM VIDEO ENDOSCOPE EC-760P-V/L
• Type of Device: COLONOSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 25885 38; JA 2588538
• MDR Report Key: 18003172
• MDR Text Key: 326476867
• Report Number: 1000513161-2023-00071
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 14547410368878
• UDI-Public: (01)14547410368878(11)211101
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: EC-760P-V/L
• Device Catalogue Number: N/A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/25/2023
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1