MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 15CM

Model Number 360-1580-02

Device Problems Output Problem (3005); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 05/01/2022

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

The throw adjuster is very heavy to move, and it is difficult to hit the exact point where it should stop.Moving the selector is not smooth, but choppy the doctor thinks it is in place, but if it is slightly in front, it shoots 33 mm, even though the choice was meant to be 23 mm.Experienced very dangerous, and therefore the pbus that have a heavy button are discarded.

Manufacturer Narrative

A review of the dhrs of the top level and sublots as well as the inspection records was conducted, and no deviations or non-conformances were found relating to this issue.There were 2 opened units returned by the customer for review.A visual in functional investigation was performed and it was found that the throw adjustor was extremely sticky and would not slide smoothly between length markers for one of the units.This results in difficulty securing the throw adjustor to a set length and the potential for the device taking a longer specimen than desired when firing the biopince.The second unit did not have any detectable defects.It was able to be fired without issue and the throw adjustor slid smoothly.An investigation into the sticky throw adjustor found that the most probable cause is an inadequate coating of teflon on the component, resulting in a significant increase of friction between the adjustor and the housing of the device.The operational procedure outlining the assembly of the biopince ultra devices was updated to develop a more robust teflon coating and final inspection process for the completed units.Training was provided to the operators to ensure proper adherence to the relevant procedure.

Event Description

The throw adjuster is very heavy to move, and it is difficult to hit the exact point where it should stop.Moving the selector is not smooth, but choppy.The doctor thinks it is in place, but if it is slightly in front, it shoots 33 mm, even though the choice was meant to be 23 mm.Experienced very dangerous, and therefore the pbus that have a heavy button are discarded.

Manufacturer Narrative

The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.

Event Description

1.The throw adjuster is very heavy to move, and it is difficult to hit the exact point where it should stop.Moving the selector is not smooth, but choppy the doctor thinks it is in place, but if it is slightly in front, it shoots 33 mm, even though the choice was meant to be 23 mm.Experienced very dangerous, and therefore the pbus that have a heavy button are discarded.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 15CM
• 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: 14841266
• MDR Text Key: 295324333
• Report Number: 0001625425-2022-01036
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00886333224029
• UDI-Public: 00886333224029
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 360-1580-02
• Device Catalogue Number: 360-1580-02
• Device Lot Number: 11404556
• 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: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other