MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT

Model Number 370-1080-03

Device Problem Failure to Obtain Sample (2533)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2024

Event Type  malfunction  

Event Description

Reporter indicated that during a renal biopsy, used two different biopsy guns first unit was fired 4 times with no sample.Second unit was fired 3 times with no sample.

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.

Manufacturer Narrative

A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.There is one other complaint reported in the lot number.The customer did not return any samples for evaluation.Additionally, no photographic or visual evidence was submitted that would have allowed this allegation to be reviewed.Without the necessary evidence, a thorough investigation cannot be performed.Determining a root cause and corrective action is not possible.If the samples are returned at a later date, then this complaint may be reopened for re-evaluation.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
• Type of Device: BIOPINCE
• 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: 18878241
• MDR Text Key: 337549396
• Report Number: 0001625425-2024-00961
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00886333209910
• UDI-Public: 00886333209910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

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
• Device Operator: Health Professional
• Device Model Number: 370-1080-03
• Device Lot Number: 11497267
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2023
• 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