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  

Manufacturer Narrative

N/a.

Event Description

On april 1, 2022, fujifilm healthcare americas 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.

• 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
• MDR Report Key: 14135370
• MDR Text Key: 289436258
• Report Number: 1000513161-2022-00005
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• 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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/01/2022
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male