MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT 20GA X 9CM

Model Number	701120090
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/23/2021
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
Supercore 20gx9cm falling apart mirroring the recall issues we recently had with the 18 supercores.Unfortunately when the instrument fell apart it resulted in a needle stick of the dirty needle to our physician upon the malfunction.We pulled the entire lot off the shelf in fear of this happening again.
Additional Manufacturer Narrative
A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.No sample or images were available for evaluation.However, due to this issue being reported numerous times for this part, the complaint was confirmed.Argon medical devices has received other complaints that the supercore semi-automatic biopsy instrument is coming apart during or prior to use.The plastic housing and plunger can be separated more easily.Capa 2021-061 has been opened to document our investigation into the cause of this problem and the corrective action that are being taken to ensure that this never happens again.
Event or Problem Description
Supercore 20gx9cm falling apart mirroring the recall issues we recently had with the 18 supercores.Unfortunately when the instrument fell apart it resulted in a needle stick of the dirty needle to our physician upon the malfunction.We pulled the entire lot off the shelf in fear of this happening again.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT 20GA X 9CM
• Common Device Name: SUPERCORE BIOPSY
• 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: 13227217
• Report Number: 0001625425-2022-00923
• Device Sequence Number: 3918936
• Product Code: KNW
• UDI-Device Identifier: 00886333005857
• UDI-Public: 00886333005857
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K974814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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: 12/20/2023
• Device Model Number: 701120090
• Device Catalogue Number: 701120090
• Device Lot Number: 11241619
• 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: 12/24/2021
• Supplement Date Received by Manufacturer: 12/24/2021
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/14/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1625425-09/30/2021-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown