MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. BIOPINCE ULTRA; INSTRUMENT, BIOPSY

Lot Number 11472338

Device Problem Defective Device (2588)

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

Event Date 05/02/2023

Event Type  malfunction  

Event Description

Biopince biopsy device failed in prepping for the biopsy.Did not affect patient.Manufacturer response for biopince biopsy device, biopince (per site reporter): argon medical is investigating the manufacturing issue.

• Brand Name: BIOPINCE ULTRA
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd.; athens TX 75751
• MDR Report Key: 16973606
• MDR Text Key: 315678614
• Report Number: 16973606
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 11472338
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: Black Or African American