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

Model Number	701118150
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
In connection with biopsy, the biopsy needle breaks.It is discovered then, we will put the tissue sample on millipore.Then the inner part is completely loose and we cannot get any tissue sample out of the "sled".If there is one at all.Update: (translated) from danish agency.In connection with ultrasonically guided biopsy of liver metastasis, the inner needle goes all the way out by pushing it into place, the inner needle does not enter the outer needle as it should (when the tissue sample from the metastasis must be secured on millipore paper), but into the finger of the doctor.The spring in the needle broke.Has been reported as an industrial injury.It fails to get the tissue sample out.Therefore it was necessary to take a new biopsy from liver the metastases, at increased risk of patient.
Additional Manufacturer Narrative
Corrected information provided in h.6.And h.11.A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.One opened sample was returned from the customer for review.A visual inspection was performed on the returned product.It was found that the plunger came off, inhibiting the device to function as intended.The complaint was confirmed.Sustaining engineering project has been initiated to investigate the issue in detail and identify the root cause and implement the corrective action to address the issue.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded.A review of the sample returned by the customer was performed.One sealed sample and one opened sample were returned.The customer returned the pusher wire and the cartridge.The were was no damage found to the returned product.The customer did not return the filter and without the filter, it is not possible to evaluate the filter expansion defect reported by the customer.Therefore, the complaint could not be confirmed.Since the complaint could not be confirmed, no further evaluation or corrective action is required at this time.

• 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: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19189461
• Report Number: 0001625425-2024-01002
• Device Sequence Number: 18218950
• Product Code: KNW
• UDI-Device Identifier: 00886333005888
• UDI-Public: (01)00886333005888(17)290925(10)11499933
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2024

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 Lot Number: 11499933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• 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: 03/27/2024
• Supplement Date Received by Manufacturer: 06/20/2024; 07/16/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 07/16/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown