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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE MECHANICAL LITHOTRIPTOR V
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AOMORI OLYMPUS CO., LTD. SINGLE USE MECHANICAL LITHOTRIPTOR V Back to Search Results
Model Number BML-V442QR-30
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/27/2024
Event Type  malfunction  
Event Description
It was reported, the endoscopic therapy distal tip for passing guidewire was teared.The issue occurred before insertion the endotherapy distal tip into the duoden endoscope.There were no reports of patient harm.
 
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
SINGLE USE MECHANICAL LITHOTRIPTOR V
Type of Device
SINGLE USE MECHANICAL LITHOTRIPTOR
Manufacturer (Section D)
AOMORI OLYMPUS CO., LTD.
2-248-1 okkonoki
kuroishi-shi, aomori 036-0 357
JA  036-0357
Manufacturer (Section G)
AOMORI OLYMPUS CO., LTD.
2-248-1 okkonoki
kuroishi-shi, aomori 036-0 357
JA   036-0357
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19125562
MDR Text Key341363466
Report Number9614641-2024-00929
Device Sequence Number1
Product Code LQC
UDI-Device Identifier04953170218422
UDI-Public04953170218422
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
CLASS2-EXMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBML-V442QR-30
Device Lot NumberLOT 38K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/28/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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