MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DBE BALLOON; ENTEROSCOPE AND ACCESSORIES

Model Number BS-2

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Type  No Answer Provided  

Event Description

This product bs-2 by comes from the manufacturer fujifilm corporation in a package of 5 non-sterile latex balloons.The ifus for the scope that the balloon is applied on instructs the user to high level disinfect the balloon prior to use.The process recommended makes the balloon nearly unusable, it no longer has talk on it and it doesn't inflate and deflate as expected.When reaching out to the company, the reps report that "no one does that" even though it's in the ifus.So they are recommending we don't follow the ifus as it makes the product very difficult to use and likely to break during the procedure.We have evaluated the risk at our organization and have decided to not follow the ifu as we believe it's riskier to the patient to high level disinfect and "damage the balloon" over having a non-sterile balloon in the stomach or small bowel which is not a sterile body cavity.We ask that the company either finds a way to sterilize these balloons during the manufacturing process as olympus does with their latex balloons or they remove the requirement to high level disinfect from the ifus.Photos of the package and tedious way the balloons must be dried after soaking in high level disinfectant are attached.The ifus are part of the operations manual for the pb-30 balloon controller, the machine that controls the balloon for the double balloon enteroscopy scope made by fujifilm.You can find these instructions on page 53 in chapter 9 of these ifus.We should also consider why the olympus company provides their balloons sterile and the fuji company is requiring hld processing.Is there some remote potential for a possible infection? since the fuji company has stated in their ifu literature to hld, will the liability now transfer to the user, if the process isn't followed and if an infection develops in a patient? fda safety report id# (b)(4).

• Brand Name: FUJIFILM DBE BALLOON
• Type of Device: ENTEROSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION
• MDR Report Key: 10836633
• MDR Text Key: 216350030
• Report Number: MW5097832
• Device Sequence Number: 1
• Product Code: FDA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2020
• Device Model Number: BS-2
• Device Lot Number: 1908
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1