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

Model Number	370-1080-01
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Pictures were provided for analysis.A follow-up report will be submitted once pictures are analyzed.
Event or Problem Description
The needle was cracked and sampling was not possible; this incident 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, and the empty gun occurred at the first needle.
Event or Problem Description
The needle was cracked and sampling was not possible; this incident 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, and 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 no sample returned, however, photos are attached to this complaint that allow for an inspection to take place.It was found that the pincer was pulled back and lifted away from the cutting cannula.There are stringent computer/photographic inspections that ensure the pincer is not deformed during the manufacturing process and has the proper radius.According to the per form, there was no coaxial needle used during the procedure, and there was no indication of a dermatotomy being performed.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, it is possible for the fragile pincer to be damaged by the tissues in the human body and to be bent while approaching the biopsy site.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.

• 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: 14407569
• Report Number: 0001625425-2022-01007
• Device Sequence Number: 5591562
• 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): 08/09/2022

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: 05/06/2022
• Device Model Number: 370-1080-01
• Device Catalogue Number: 370-1080-01
• Device Lot Number: 11258447
• 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: 05/12/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 08/09/2022
• 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