MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT 18GA X 15CM

Model Number	701118150
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/20/2022
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
Customer report: today there was a situation during the procedure, dr (b)(6) when using the semi automatic biopsy needle 18gax15cm.When setting the needle and pulling out the drawer, the needle broke and pierced the doctor's.Can you check if it's a problem with all batches? very serious what happened.".
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.The most likely cause of this issue was the operator not following the assembly procedure, which would allow for the tab to not fully seat in their notches.The argon wheeling engineering and quality managers have been made aware of this issue.They are continuing to improve the assembly procedure to mitigate this issue completely.
Event or Problem Description
Customer report: today there was a situation during the procedure, dr sheyla when using the semi automatic biopsy needle 18gax15cm.When setting the needle and pulling out the drawer, the needle broke and pierced the doctor's.Can you check if it's a problem with all batches? very serious what happened.".

• Brand Name: SUPERCORE BIOPSY INSTRUMENT 18GA X 15CM
• Common Device Name: SUPERCORE
• 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: 14834502
• Report Number: 0001625425-2022-01035
• Device Sequence Number: 4744325
• Product Code: KNW
• UDI-Device Identifier: 00886333005888
• UDI-Public: 00886333005888
• Combination Product (Y/N): N
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• 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
• Operator of Device: Health Professional
• Device Model Number: 701118150
• Device Catalogue Number: 701118150
• Device Lot Number: 11406377
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 06/27/2022
• 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
• 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