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

Model Number 370-1080-01

Device Problems Failure to Obtain Sample (2533); Material Twisted/Bent (2981)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 09/20/2023

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

The surgeon used the needle for the first core biopsy specimen.The patient experienced a lot of pain and discomfort.Upon obtaining the first specimen he examined the needle and saw it was bent.He then changed to another needle, the same type and size.Two more specimens were obtained.The patient did not experienced pain and discomfort with the 2nd needle.

Event Description

Dr the surgeon used the needle for the first core biopsy specimen.The patient experienced a lot of pain and discomfort.Upon obtaining the first specimen he examined the needle and saw it was bent.He then changed to another needle, the same type and size.Two more specimens were obtained.The patient did not experienced pain and discomfort with the 2nd needle.

Manufacturer Narrative

A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.One opened sample was returned from the customer for review.A visual inspection was performed on the returned products, and it was found that the tri-tips were bent out of shape, preventing the device from properly obtaining a sample, hence the complaint was confirmed.There are stringent computer and photographic inspections that ensure the cannula tri-tips are not deformed during the manufacturing process.The tri-tip damage was likely caused by the device striking a hard external surface or a hard object such as a bone or possibly getting caught on some human tissue and pulling back.Since the most likely cause for the damaged needles is related to an event within the user's environment and not a manufacturing issue, no corrective action can be implemented at this time.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 16G 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: 17941841
• MDR Text Key: 325833309
• Report Number: 0001417485-2023-00006
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00886333004386
• UDI-Public: 00886333004386
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

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
• Device Operator: Health Professional
• Device Model Number: 370-1080-01
• Device Lot Number: 11436037
• 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: 10/06/2023
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• 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): Other