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

Lot Number 2308S6

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/05/2024

Event Type  Injury  

Event Description

The devices which was attached to the endoscope used for endoscopic examination were detached from the endoscope and fell into the digestive tract twice.The products were retrieved from the digestive tract using a forceps.The procedure was completed without harm or 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.

Manufacturer Narrative

Distributors reported that they had reported incorrect information to fujifilm.The initial report stated that the customer had used the wrong tape, but the customer had not used the tape.This product must be securely attached to the endoscope with an elastic medical tape as described in ifu.Therefore, the root cause is customer error.

• 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: 18620427
• MDR Text Key: 334256736
• Report Number: 3001722928-2024-00006
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 14547410127390
• UDI-Public: 01145474101273901726073111230801102308S6
• 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,Followup
• Report Date: 03/14/2024

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 Lot Number: 2308S6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• 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