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

Model Number	360-1080-02
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the sample will be returned for investigation or not.A follow-up report will be submitted once sample is returned or more information is available.
Event or Problem Description
The first needle we opened and wanted to use was faulty, stiff and jumps the set cm which was pre-set.We were very concerned as this is very risky to our patients if this had occurred during procedure, it could have damaged other surrounding organs.I have kept the fault needle just in case we might have a rep at site or discuss this with any of your equipment reps.Is there anyone i can speak to or discuss this issue with?.
Additional 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 was no physical or video evidence provided by the customer.However, the complaint is a known and recently recurrent issue that is being address by argon.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 or Problem Description
The first needle we opened and wanted to use was faulty, stiff and jumps the set cm which was pre-set.We were very concerned as this is very risky to our patients if this had occurred during procedure, it could have damaged other surrounding organs.I have kept the fault needle just in case we might have a rep at site or discuss this with any of your equipment reps.Is there anyone i can speak to or discuss this issue with?.
Additional 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.A visual and functional investigation was performed and it was found that the throw adjustor was extremely sticky and would not slide smoothly between length markers.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.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 or Problem Description
The first needle we opened and wanted to use was faulty, stiff and jumps the set cm which was pre-set.We were very concerned as this is very risky to our patients if this had occurred during procedure, it could have damaged other surrounding organs.I have kept the fault needle just in case we might have a rep at site or discuss this with any of your equipment reps.Is there anyone i can speak to or discuss this issue with?.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 10CM
• Common Device Name: 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: 15014903
• Report Number: 0001625425-2022-01042
• Device Sequence Number: 12323502
• Product Code: KNW
• UDI-Device Identifier: 00886333224005
• UDI-Public: 00886333224005
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K904987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2025
• Device Model Number: 360-1080-02
• Device Catalogue Number: 360-1080-02
• Device Lot Number: 11418104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 06/30/2022; 06/30/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 09/12/2022; 10/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown