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

Model Number	360-1080-03
Medical Device Problem Codes	Firing Problem (4011); Activation Problem (4042)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Dr (b)(6) made the first pass and retrieved a sample.When he re-charged the biopince, it seemed to break at the handle, but appeared to recharged the device.He made another pass with the depth selector switch set to 23mm throw, and the device went beyond the 23mm depth and pierced the lunch.The patient crashed and had a neumo thorax develop.The patient was transferred to smh main and is doing well.
Additional 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.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.One opened sample was returned from the customer for review.A visual inspection and testing were performed on the returned product.It was observed that the device linkage connector was broken hence the issue cannot be duplicated.But this issue happens only when the stroke length adjuster not properly aligned with the markings.No corrective action can be taken at this time since the issue cannot be duplicated.
Event or Problem Description
Doctor (b)(6) made the first pass and retrieved a sample.When he re-charged the biopince, it seemed to break at the handle, but appeared to recharged the device.He made another pass with the depth selector switch set to 23mm throw, and the device went beyond the 23mm depth and pierced the lunch.The patient crashed and had a neumo thorax develop.The patient was transferred to smh main and is doing well.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
• Common Device Name: BIOPINCE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 17644044
• Report Number: 0001625425-2023-01191
• Device Sequence Number: 7585733
• Product Code: KNW
• UDI-Device Identifier: 00886333224012
• UDI-Public: 00886333224012
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K904987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 360-1080-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown