MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 16GA X 10CM

Model Number	370-1080-02
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Device broke the spring mechanism broke and almost hit the nurse in the eye.2nd deep abdominal biopsy, high risk.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.A visual inspection was performed on the retuned sample.The visual inspection confirmed that the linkage connecting the cocking lever and catcher components was broken at the joint.The joint of the linkage is very thin to allow the component to have the necessary flexibility to operate properly.The most likely cause of the broken linkage is that the user applied too much force when cocking the device, resulting in the weak point of the linkage breaking.There is no indication of any manufacturing defect, so no corrective action can be taken at this time.
Event or Problem Description
Device broke the spring mechanism broke and almost hit the nurse in the eye.2nd deep abdominal biopsy, high risk.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 16GA X 10CM
• Common Device Name: 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 Key: 15926408
• Report Number: 0001625425-2022-01157
• Device Sequence Number: 5225724
• Product Code: KNW
• UDI-Device Identifier: 20886333224061
• UDI-Public: 00886333224067
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K904987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2024
• Device Model Number: 370-1080-02
• Device Catalogue Number: 370-1080-02
• Device Lot Number: 11391323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown