MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE

Model Number 701218150

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/25/2023

Event Type  malfunction  

Event Description

The needle support broke, causing damage to the patient and dissatisfaction for the physician.

Manufacturer Narrative

No sample was available for evaluation.However, images were provided that showed the devices in pieces and 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.Argon has conducted an internal investigation and tracked the affected parts to a narrow time frame resulting from a specific manufacturing event.The plastic housing and plunger can be separated more easily than normal for the lots manufactured during this time frame.Capa c-2021-061 was filed.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.To ensure continued customer satisfaction, argon medical devices has decided to issue a voluntary recall of the affected lots because of the high rate of reports of unintentional disassembly of these devices.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE
• Type of Device: 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: 17798309
• MDR Text Key: 324030239
• Report Number: 0001417485-2023-00002
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K974814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701218150
• Device Lot Number: 11406221
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1625425-09/30/2021-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other