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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM BALLOON BS-4 ENTEROSCOPE AND ACCESSORIES

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FUJIFILM CORPORATION FUJIFILM BALLOON BS-4 ENTEROSCOPE AND ACCESSORIES Back to Search Results
Model Number BS-4
Device Problems Increase in Pressure (1491); Failure to Deflate (4060)
Patient Problems Abdominal Pain (1685); Laceration(s) (1946); Gastrointestinal Hemorrhage (4476)
Event Date 12/17/2020
Event Type  Injury  
Manufacturer Narrative
If any additional relevant information is provided, a supplemental report will be submitted. Ref: internal complaint number (b)(4).
 
Event Description
Double-balloon endoscopy was started on a patient with crohn's disease and strong small intestinal adhesions. The balloon bs-4 at the tip of the scope en-580t ceased to inflate during ileal insertion. The balloon controller pb-20 was removed, and a 10 ml syringe was connected to try to deflate the balloon. The balloon did not deflate, but was able to inflate. Immediately after inflating, the patient complained of severe abdominal pain, and a laceration of the small intestinal mucosa and significant bleeding were observed. Conservative treatment by blood transfusion was performed, but the patient got into shock. Angiography was performed which identified the bleeding point artery, so hemostasis was performed by coiling.
 
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Brand NameFUJIFILM BALLOON BS-4
Type of DeviceENTEROSCOPE AND ACCESSORIES
Manufacturer (Section D)
FUJIFILM CORPORATION
798 miyanodai kaisei-machi
ashigarakami-gun, kanagawa 258-8 538
JA 258-8538
MDR Report Key11169667
MDR Text Key231305972
Report Number1000513161-2021-00001
Device Sequence Number1
Product Code FDA
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Biomedical Engineer
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 Received01/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBS-4
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date01/08/2021
Device Age7 YR
Event Location Hospital
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/14/2021 Patient Sequence Number: 1
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