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

Model Number	370-1080-02
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is indicated as available for return.As of the date of this report, sample has not been returned.A follow-up report will be submitted once sample has been received and reviewed.
Event or Problem Description
Physician reports that during procedure with several units of the same biopince: advance selection failure, select an advance before firing 23mm and the needle fires at 33mm.The advance is changed only during the shot.Physician consider it a serious incident, since they can perforate any structure due to this failure, creating very serious injuries.Also from the same biopince box, when trying to shoot them inside the patient, the shot cannot be activated.And after, the fourth unit, also from the same biopince box, was only charged outside when showing the sound to the patient.But once loaded it was impossible to activate the shot.That last unit of the device without contact with patient, has been received from the hospital for study by argon cleaned within a double bag.Hospital has more units of the material blocked from this lot number.Hospital needs a letter explaining the root cause of the incident and wacrees needs credit note per 1 unit of the same reference.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 16GA 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: 15656686
• Report Number: 0001625425-2022-01118
• Device Sequence Number: 5882663
• Product Code: KNW
• UDI-Device Identifier: 00886333224067
• UDI-Public: 00886333224067
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 10/23/2022

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: 06/16/2026
• Device Model Number: 370-1080-02
• Device Catalogue Number: 370-1080-02
• Device Lot Number: 11418104
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 10/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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