MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 20CM

Model Number 360-2080-01

Device Problem Failure to Obtain Sample (2533)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2023

Event Type  malfunction  

Event Description

Attempt at intrahepatic biopsy which was a failure, because biopince did not recover liver material.

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.

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.When the device is cocked, the pincer comes out of its window and becomes exposed to the tissues and structures present during the operation.It is also possible that the needle set was inserted into tissue that was too hard for the sensitive pincer, pushing it flat.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.

Event Description

Attempt at intrahepatic biopsy which was a failure, because biopince did not recover liver material.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 20CM
• 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: 17951488
• MDR Text Key: 326409917
• Report Number: 0001625425-2023-01228
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00886333004348
• UDI-Public: 00886333004348
• 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: 11/29/2023

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
• Device Operator: Health Professional
• Device Model Number: 360-2080-01
• Device Lot Number: 11471472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• 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
• Patient Outcome(s): Other