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

Model Number	360-1080-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The investigation is ongoing.A follow-up report will be provided once the investigation has been completed.
Event or Problem Description
Application/procedure: taking a biopsy.Process/product group: biopsy needle.Complaint: the tip of the needle has a damage.1 of the 3 end points seems different.This has already been observed when passing through the skin.Before the biopteer entered the patient¿s skin, the device was not dropped.The device is fired at most 1x to illustrate the sound of the device to the patient.The needle felt a bit frayed when inserted into the patient, it looked like there was some kind of barb on the tip.The needle was then removed without biopsying into the patient and the tip was inspected.It indeed felt uneven, but it was not visible what exactly was going on.Presumably 1 of the teeth of the outer needle was standing slightly outward.Punctured through the patients skin, but no biopsy taken, device is contaminated.This complaint is internally registrated under no.Fmh.20-31 by the fmh medical quality department.
Event or Problem Description
Follow up.

• Brand Name: BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18GX10CM
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10359957
• Report Number: 1625425-2020-00452
• Device Sequence Number: 11390093
• 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,Followup
• Report Date (Section B): 08/03/2020

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
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 08/11/2020
• 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