MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 20CM

Model Number	360-2080-02
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.
Event or Problem Description
The adjusted length of the biopince ultra 18g 20 device didn't stay as adjusted and needed at 23mm.When taking the biopsy the throw length changed to 33mm.Luckily this didnt cause an issue however there was a huge surprise to the operator and could have been very dangerous for the patient.
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.
Event or Problem Description
The adjusted length of the biopince ultra 18g 20 device didn't stay as adjusted and needed at 23mm.When taking the biopsy the throw length changed to 33mm.Luckily this didn't cause an issue however there was a huge surprise to the operator and could have been very dangerous for the patient.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 20CM
• 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: 13115506
• Report Number: 0001625425-2021-01240
• Device Sequence Number: 14646225
• Product Code: KNW
• UDI-Device Identifier: 00886333224043
• UDI-Public: 00886333224043
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 12/29/2021

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 Model Number: 360-2080-02
• Device Catalogue Number: 360-2080-02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 12/29/2021
• 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