MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ENDOSCOPE MODEL EG-760R; GASTROSCOPE AND ACCESSORIES

Model Number EG-760R

Device Problems Retraction Problem (1536); Mechanical Jam (2983)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) of Esophagus (2398)

Event Date 03/18/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, fujifilm corporation became aware of an adverse event involving eg-760r during a routine endoscopy procedure.A simple biopsy was performed and no accessories were inside the working channel.No problems or abnormal noises were identified during the first part of the procedure.Towards the end of the procedure, the bending section of the scope became locked while the physician attempted to make an angulation and was unable to unlock in order to remove the device.The physician managed to remove the scope, however, the patient's esophagus was injured in the process.The physician used another device to contain the bleeding and clip the patient.The patient was in stable condition following the procedure and hospitalization was not required.There was no death associated with the event.

Manufacturer Narrative

The field service engineer visited the hospital and received the device.The bending section was locked in an upright position, approximately at 100 degrees.A supplemental report will be submitted pending investigation results.

Manufacturer Narrative

On january 2, 2023, fujifilm corporation concluded the root cause investigation of eg-760r.The reported malfunction could not be reproduced during the inspection of the scope.All parts were operating within normal expectations and no apparent abnormalities were found with the bending or angulation function.Therefore, the root cause could not be determined.

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 october 1, 2021 and october 12, 2023, due to fda 483 observations issued to fujifilm corporation on september 22, 2023.This supplement includes missing or incorrect information in the original mdr filing, and previous supplements where applicable.

• Brand Name: FUJIFILM ENDOSCOPE MODEL EG-760R
• Type of Device: GASTROSCOPE AND ACCESSORIES
• 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: safety officer ; 700 konaka-cho; sano city, tochigi 327-0-00
• MDR Report Key: 14117459
• MDR Text Key: 289323018
• Report Number: 3001722928-2022-00006
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K172916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EG-760R
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male