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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE BIOPSY FORCEPS
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AOMORI OLYMPUS CO., LTD. DISPOSABLE BIOPSY FORCEPS Back to Search Results
Model Number FB-231D
Medical Device Problem Codes Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/15/2024
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported during a robotic lung navigation procedure, the tip broke off inside the patient's lung.The tip was retrieved and the procedure was completed.There was no reported patient harm or impact due to this event.
 
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Brand Name
DISPOSABLE BIOPSY FORCEPS
Common Device Name
DISPOSABLE BIOPSY FORCEPS
Manufacturer (Section D)
AOMORI OLYMPUS CO., LTD.
2-248-1 okkonoki
kuroishi-shi, aomori 036-0 357
JA  036-0357
MDR Report Key18867882
Report Number2429304-2024-00165
Device Sequence Number3008899
Product Code EOQ
UDI-Device Identifier04953170389559
UDI-Public04953170389559
Combination Product (Y/N)N
Initial Reporter StateAZ
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 Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/08/2024
Report Date (Section F) 02/16/2024
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 NumberFB-231D
Device Lot Number2YV
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date02/16/2024
Event Location Hospital
Date Report to Manufacturer02/16/2024
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/08/2024
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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