MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18G X 15CM

Model Number 360-1580-01

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The sample is indicated as available for evaluation.A follow-up report will be submitted once the sample has been received and reviewed.

Event Description

The needle was broken inside, the needle was left in the device when triggered it.It is very dangerous.The event was found after it was used on the patient, but it did not break off inside the patient.

Manufacturer Narrative

H3 other text: placeholder.

Event Description

Follow up.

• Brand Name: BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18G X 15CM
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11310947
• MDR Text Key: 232512634
• Report Number: 1625425-2021-00844
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00886333004355
• UDI-Public: 00886333004355
• Combination Product (y/n): N
• PMA/PMN Number: K904987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2022
• Device Model Number: 360-1580-01
• Device Catalogue Number: 360-1580-01
• Device Lot Number: 11289335
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other