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	Pain (1994)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Physician reports that during use of the two devices it is observed that they do not take a sample and the grip tab appears twisted.The patient felt a lot of pain when the gun was removed the hospital didn¿t send samples, but send several imagens.They need a letter explaining the root cause of the incident and wacrees needs credit note per 2 units of the same reference.
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Images were provided for investigation.A follow-up report will be provided once the images have been reviewed.
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 evidence returned by the customer, but there were photographs that allowed for an inspection of the biopince needle set to take place.It was found that the pincer had been badly arched and bent out of shape and the tri-tips appeared to have been badly bent and curled inward.The tri-tip damage observed in the pictures of the needle set is indicative of the device striking some hard external surface or some hard internal object, such as a bone or calcified tissue.Additionally, there was no indication on the per that a coaxial introducer was used with the device.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, the pincer can be pushed flat as it is a very sensitive component.Additionally, once a pincer is flattened, it becomes possible to hit the window structure when firing, which results in the pincer folding up in an arch shape, as was seen in the supplied photographs.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 or Problem Description
Physician reports that during use of the two devices it is observed that they do not take a sample and the grip tab appears twisted.The patient felt a lot of pain when the gun was removed (see attached photographs) the hospital didn¿t send samples, but send several images.They need a letter explaining the root cause of the incident and "wacrees" needs credit note per 2 units of the same reference.

• 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: 14644243
• Report Number: 0001625425-2022-01021
• Device Sequence Number: 5219395
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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
• Device Expiration Date: 12/14/2024
• Device Model Number: 360-1080-02
• Device Catalogue Number: 360-1080-02
• Device Lot Number: 11400277
• Was Device Available for Evaluation?: No
• 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: 06/07/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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