MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE¿ AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18GX10CM

Model Number	360-1080-01
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample device is indicated as unavailable for evaluation.Images were provided, however, they could not confirm the complaint.Without the sample to review, a root cause cannot be determined.If additional information is provided in the future, a follow-up report will be provided.
Event or Problem Description
Application/procedure: biopsy soft tissue / breast.Process/product group: biopince to take a breast biopsy.Complaint situation: last week (week from (b)(6) 2020) a woman with breast cancer had a biopsy, and the next day in the mri scan.A breast photo was taken yesterday (monday (b)(6) 2020) and then they saw the piece of metal, also later on the mri scan.Her breast will be amputated after the irradiation and then our request was to keep that metal piece in due time.So that we can send this to argon for investigation.The breast will be amputated in the coming period, after that they will take out the metal piece and keep it for us.So that it can be sent to argon.The complaint was already internally registered under no.(b)(4) by the quality department.

• Brand Name: BIOPINCE¿ AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18GX10CM
• Common Device Name: BIOPINCE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10165242
• Report Number: 1625425-2020-00356
• Device Sequence Number: 19433122
• Product Code: KNW
• UDI-Device Identifier: 00886333004379
• UDI-Public: 00886333004379
• Combination Product (Y/N): N
• PMA/510(K) Number: K904987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2020

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 Expiration Date: 10/10/2022
• Device Model Number: 360-1080-01
• Device Catalogue Number: 360-1080-01
• Device Lot Number: 11279219
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other