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

Model Number 701118150

Device Problem Failure to Obtain Sample (2533)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/27/2023

Event Type  Injury  

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 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.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT 18GA X 15CM
• Type of Device: 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
• MDR Text Key: 341120714
• Report Number: 0001625425-2024-01002
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00886333005888
• UDI-Public: 00886333005888
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K974814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2024

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
• Device Operator: 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other