MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM HOOD MODELS DH-28GR; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number DH-28GR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  Injury  

Manufacturer Narrative

This product must be securely attached to the endoscope with an elastic medical tape as described in ifu.However, this user was using a non-elastic tape.It is believed that the product fell due to insufficient fixation.This malfunction is easily recognizable from the endoscopic image and can be easily retrieved from the gastrointestinal tract.

Event Description

This device which was attached to the endoscope used for endoscopic examination was detached from the endoscope and fell into the digestive tract.The product was retrieved from the digestive tract using a forceps.The procedure was completed without harm or injury.The device was discarded at the facility.

• Brand Name: FUJIFILM HOOD MODELS DH-28GR
• Type of Device: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• Manufacturer (Section G): FUJIFILM HEALTHCARE MANUFACTURING SANO; 700 konaka-cho; sano city, tochigi 327-0 001; JA 327-0001
• Manufacturer Contact: safety officer ; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538 ; JA 258-8538
• MDR Report Key: 18620428
• MDR Text Key: 334257917
• Report Number: 3001722928-2024-00005
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DH-28GR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian