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 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.

Manufacturer Narrative

Fujifilm does not suspect there to be any abnormality with the device as it has been continuously used at the facility since the event occurred in 2021.Due to limited information, a definitive root cause could not be determined.There have been no reports of similar complaints received and the reported event is presumed to be an isolated issue.It is strongly recommended to follow the ifus for the gw-100 which state that the air supply from the light source should be stopped before using gw-100.If additional information regarding this event is obtained, a supplemental report will be submitted.

Manufacturer Narrative

This supplement is being submitted to fda as a result of fujifilm corporation's commitment to perform a retrospective review of all mdrs submitted between (b)(6) 2021 and (b)(6) 2023, due to fda 483 observations issued to fujifilm corporation on (b)(6) 2023.This supplement includes missing or incorrect information in the original mdr filing, and previous supplements where applicable.

• 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
• Manufacturer (Section G): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer Contact: 2-1-3 kitayuguchi; hanamaki-shi, iwate 025-0-301
• MDR Report Key: 16911551
• MDR Text Key: 315004206
• Report Number: 3001722928-2023-00025
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• 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
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other