MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ENDOSCOPIC CO2 REGULATOR GW-100; INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE

Model Number GW-100

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 01/01/2021

Event Type  Injury  

Event Description

On (b)(6) 2023, fujifilm healthcare americas corporation became aware of an event involving gw-100.The reported event occurred in 2021, however, the exact date of the event is unknown.It was reported that a gastrointestinal endoscopy was performed while simultaneously using co2 gas supplied from the gw-100 and air supplied from the endoscope when a perforation occurred.Fujifilm was unable to obtain additional details regarding the patient's status and device information.As such, this report is being submitted in an abundance of caution.

• Brand Name: FUJIFILM ENDOSCOPIC CO2 REGULATOR GW-100
• Type of Device: INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 17013278
• MDR Text Key: 316097637
• Report Number: 1000513161-2023-00029
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GW-100
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/10/2023
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other