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

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.

• Brand Name: FUJIFILM BALLOON BS-4
• Type of Device: ENTEROSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 11169667
• MDR Text Key: 231305972
• Report Number: 1000513161-2021-00001
• Device Sequence Number: 1
• Product Code: FDA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• 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 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: BS-4
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/08/2021
• Device Age: 7 YR
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR