MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 10CM

Model Number 360-1080-02

Device Problem Failure to Obtain Sample (2533)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  malfunction  

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 product, and it was found that the pincer was flattened, inhibiting it from properly obtaining a sample.The complaint was confirmed.There are stringent computer and photographic inspections that ensure the pincer is not deformed during the manufacturing process and has the proper radius.An internal investigation has been opened to investigate the issue in detail and it is under effectiveness phase.A review of the complaints database was conducted, and over the previous six months, multiple similar complaints were found related to this part number 360-1080-02.There were multiple similar complaints found related to this lot number.

Event Description

An ultrasound manager reported that during a kidney biopsy, 4 passes were performed with no specimen received.There was no patient injury.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 10CM
• Type of Device: BIOPINCE ULTRA
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19015333
• MDR Text Key: 339331751
• Report Number: 0001625425-2024-00973
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00886333224005
• UDI-Public: 00886333224005
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 360-1080-02
• Device Lot Number: 11482911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• 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