MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DOUBLE BALLOON ENDOSCOPE EN-580T; ENTEROSCOPE AND ACCESSORIES

Model Number EN-580T

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

There were no abnormal protrusions on the insertion part that would cause lacerations.The event is considered to be a known complication in endoscopy as stated by the endoscopist.If any additional relevant information is provided, a supplemental report will be submitted.

Event Description

Double-balloon endoscopy was conducted on a patient with crohn disease.While the endoscope was being pulling out, a laceration was found in the lower ileum.After clipping under endoscopy, an artificial anus was created by emergency surgery.The patient has already been discharged.Per the endoscopist, since the patient had crohn disease, the intestinal wall was rigid and fragile.It is probable that friction with the insertion part of the scope led to the laceration.

• Brand Name: FUJIFILM DOUBLE BALLOON ENDOSCOPE EN-580T
• Type of Device: ENTEROSCOPE 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 ; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538 ; JA 258-8538
• MDR Report Key: 11169662
• MDR Text Key: 230344369
• Report Number: 3001722928-2021-00002
• Device Sequence Number: 1
• Product Code: FDA
• UDI-Device Identifier: 04547410238747
• UDI-Public: (01)04547410238747
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EN-580T
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/24/2013
• 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): Required Intervention
• Patient Age: 48 YR