MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 20CM

Model Number	360-2080-02
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4).5 times the gun failed after two or three uses, making vacuum punctures without bringing back pieces of tissue, which increases the attack on the prostate and therefore the risk of hemorrhage and infection and which required for once, 7 guns to make 12 carrots (on average 2) 6 times the procedure was followed by hospitalization or consumption of heavy treatment.- a night hospitalization at the (b)(6) hospital for the same situation of hemorrhage/catheterization with a week of hospitalization for a fragile grandfather.- prostatitis with prescription of rocéphine at home.- hospitalization in cardella for severe prostatitis bordering on septic shock the same evening of the puncture, rocéphine amiklin, 4 days of hospitalization.- a survey for acute urine retention.- a hematoma responsible for dysuria, prescription of bactrim and alpha blocker.- urethrorrhagia giving in to hyper hydration.
Additional Manufacturer Narrative
Ten incidents were reported under one product experience report.Argon reached out to the reporter for additional information.Argon did not receive any additional information or ten separate reports for the incidents.The 10 incidents are reported under (b)(4).According to the report, two out of ten samples will be returned for investigation.At this point, it is unclear which samples will get returned.Argon is investigating the reported events and a follow-up report will be submitted when new information becomes available and investigation is completed.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.The customer did not return any samples for evaluation.Additionally, no photographic or visual evidence was submitted that would have allowed this allegation to be reviewed.Without the necessary evidence, a thorough investigation cannot be performed.Determining a root cause and corrective action is not possible.No corrective action is required at this point.If the samples are returned at a later date, then this complaint may be reopened for re-evaluation.
Event or Problem Description
Out of 16 biopsies, there were 10 incidents.5 times the gun failed after two or three uses, making vacuum punctures without bringing back pieces of tissue, which increases the attack on the prostate and therefore the risk of hemorrhage and infection and which required for once, 7 guns to make 12 carrots (on average 2) 6 times the procedure was followed by hospitalization or consumption of heavy treatment.A night hospitalization at (b)(6) hospital for the same situation of hemorrhage/catheterization with a week of hospitalization for a fragile grandfather.Prostatitis with prescription of rocéphine at home.Hospitalization in cardella for severe prostatitis bordering on septic shock the same evening of the puncture, rocéphine amiklin, 4 days of hospitalization.A survey for acute urine retention.A hematoma responsible for dysuria, prescription of bactrim and alpha blocker.Urethrorrhagia giving in to hyper hydration.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 20CM
• 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: 18322289
• Report Number: 0001625425-2023-01266
• Device Sequence Number: 7520625
• Product Code: KNW
• UDI-Device Identifier: 00886333224043
• UDI-Public: (01)00886333224043(17)260328(10)11469345
• Combination Product (Y/N): N
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2024

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 Expiration Date: 03/28/2026
• Device Model Number: 360-2080-02
• Device Lot Number: 11469345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/01/2023; 09/04/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 02/16/2024; 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• 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: Hospitalization
• Patient Sex: Unknown