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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN EXTRACTION BALLOON V
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AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN EXTRACTION BALLOON V Back to Search Results
Model Number B-V233P-B
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/24/2024
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that two balloons broke and fell in the patient's body.The fragments were swept out of the duct with another extraction balloon and the procedure was completed successfully with a similar device.This report is related to linked patient identifier (b)(6).
 
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Brand Name
SINGLE USE 3-LUMEN EXTRACTION BALLOON V
Common Device Name
SINGLE USE 3-LUMEN EXTRACTION BALLOON
Manufacturer (Section D)
AOMORI OLYMPUS CO., LTD.
2-248-1 okkonoki
kuroishi-shi, aomori 036-0 357
JA  036-0357
MDR Report Key19570474
Report Number2429304-2024-0000308
Device Sequence Number6112319
Product Code FGE
UDI-Device Identifier04953170368714
UDI-Public04953170368714
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/19/2024
Report Date (Section F) 05/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberB-V233P-B
Device Lot Number33V
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date05/24/2024
Event Location Hospital
Date Report to Manufacturer05/24/2024
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/19/2024
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
AIR SYRINGES FROM MULTI-3V EXTRACTION BALLOON.; DUODENOSCOPE; GUIDEWIRE
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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