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

Model Number	701118150
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
After the device was fired in the target area, when attempted to expose the specimen notch to collect biopsy sample, the housing broke and the plunger detached from the housing.Even though it was a very dangerous situation for the patient and the doctor, fortunately it did not harm anyone.Sugan check of the returned unit: the housing of the returned device was opened.The snap fit latch tabs were not broken, however, there seemed flash on the goose neck portion of the latch tab.
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.One opened device was returned for evaluation.Visual inspection found that the body of the device was split proximally with the spring released and the stylet separated out.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 the plastic housing and plunger can be separated more easily than normal.Capa (b)(6) 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
After the device was fired in the target area, when attempted to expose the specimen notch to collect biopsy sample, the housing broke and the plunger detached from the housing.Even though it was a very dangerous situation for the patient and the doctor, fortunately it did not harm anyone.Sugan check of the returend unit: the housing of the returned device was opened.The snap fit latch tabs were not broken, however, there seemed flash on the goose neck portion of the latch tab.

• 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: 15228218
• Report Number: 0001625425-2022-01061
• Device Sequence Number: 14595484
• 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: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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 Model Number: 701118150
• Device Catalogue Number: 701118150
• Device Lot Number: 11402269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/03/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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