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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 16GA X 10CM
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ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 16GA X 10CM Back to Search Results
Model Number 370-1080-02
Device Problem Failure to Obtain Sample (2533)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2023
Event Type  malfunction  
Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
 
Event Description
2 subsequent ultrasound guided liver biopsies had biopsy samples taken with needle appropriately positioned, needle gun deployed, but no biopsy sample obtained.Same technique as hundreds of successful prior standard liver biopsies.This creates additional patient risk of bleeding as further biopsy samples are required.
 
Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.Three unopened sample was returned from the customer for review.A visual inspection and testing was performed on the ret urned product.Laboratory kidney biopsy testing was performed with the three unused biopince device and it was able to obtain 9 out of 9 samples with no defects.No corrective action can be taken at this time since the issue cannot be duplicated.
 
Event Description
2 subsequent ultrasound guided liver biopsies had biopsy samples taken with needle appropriately positioned, needle gun deployed, but no biopsy sample obtained.Same technique as hundreds of successful prior standard liver biopsies.This creates additional patient risk of bleeding as further biopsy samples are required.
 
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Brand Name
BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 16GA X 10CM
Type of Device
BIOPINCE
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
elnaz rahman
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key18194006
MDR Text Key328822895
Report Number0001625425-2023-01244
Device Sequence Number1
Product Code KNW
UDI-Device Identifier00886333224067
UDI-Public00886333224067
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K904987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number370-1080-02
Device Lot Number11484188
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/06/2023
Initial Date FDA Received11/22/2023
Supplement Dates Manufacturer Received11/06/2023
Supplement Dates FDA Received12/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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