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

Model Number 370-1080-02

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2022

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

Device broke the spring mechanism broke and almost hit the nurse in the eye.2nd deep abdominal biopsy, high risk.

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 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
• 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 Key: 15926408
• MDR Text Key: 307919561
• Report Number: 0001625425-2022-01157
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 20886333224061
• UDI-Public: 00886333224067
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other