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

Model Number	370-1080-01
Health Effect - Clinical Codes	Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On july 8, lymph node puncture, the tissue could not be removed during the operation.After taking out the biopsy needle and trying several times, it was found that the spring fell off.The director said that it had caused psychological and physical damage to doctors and patients.; this event was not used with a coaxial guide needle.The gun was not tested before use.The instrument was not rotated 360 degrees when it was taken out.The range of use was 23mm.The empty gun occurred at the first needle.
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 one opened unit returned by the customer for review.An inspection of the needle set and internal components found that the pincer had been very badly deformed and bent back.It was also found that the cutting cannula was not properly glued into the carriage and had broken free, inhibiting the function of the biopince device.There are stringent computer/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.Without the use of a proper sized coaxial needle, such as the inner diameter being too small, the pincer can be damaged.It is also possible that the needle set was inserted into tissue that was too hard for the sensitive pincer, causing it to deform.Additionally, the exact conditions of the biopsy performed in the user environment is not known.If the device is fired into either very fatty tissue or some sort of calcified tissue then it is possible for the needle set components to bend out of shape and the pincer to have a failure when collecting a sample and resulting in an incomplete or no sample defect.It is likely that there was not enough glue applied to the internal components or that the device was not allowed enough time to cure, resulting in a weakened gluing application.The area supervisor was made aware of the issue and training was provided to the manufacturing operators to ensure the machinery and assembly line runs properly.Argon will continue to monitor for recurrence of the defect.
Event or Problem Description
On july 8, lymph node puncture, the tissue could not be removed during the operation.After taking out the biopsy needle and trying several times, it was found that the spring fell off.The director said that it had caused psychological and physical damage to doctors and patients.This event was not used with a coaxial guide needle.The gun was not tested before use.The instrument was not rotated 360 degrees when it was taken out.The range of use was 23mm.The empty gun occurred at the first needle.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 16G 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: 15248655
• Report Number: 0001625425-2022-01063
• Device Sequence Number: 5847452
• Product Code: KNW
• UDI-Device Identifier: 00886333004386
• UDI-Public: 00886333004386
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2023
• Device Model Number: 370-1080-01
• Device Catalogue Number: 370-1080-01
• Device Lot Number: 11315540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/19/2022
• 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