MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 16G X 10CM

Model Number	370-1080-01
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.
Event or Problem Description
Physician reports that once the device is used, no sample is taken.And in one of the three used units, the doctor saw recoil of the tap that holds the sample with the danger of tearing for the patient.Hospital needs a letter explaining the root cause of the incidents and wacrees needs credit note per 3 units of the same reference.
Additional Manufacturer Narrative
According to the product experience report, there were no sample available for return.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the results of this investigation are inconclusive and determining a definite root cause and corrective action is not possible.
Event or Problem Description
Physician reports that once the device is used, no sample is taken.And in one of the three used units, the doctor saw recoil of the tap that holds the sample with the danger of tearing for the patient.Hospital needs a letter explaining the root cause of the incidents and wacrees needs credit note per 3 units of the same reference.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 16G X 10CM
• 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: 14165230
• Report Number: 0001625425-2022-00991
• Device Sequence Number: 11981479
• Product Code: KNW
• UDI-Device Identifier: 00886333004386
• UDI-Public: 00886333004386
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/27/2023
• Device Model Number: 370-1080-01
• Device Catalogue Number: 370-1080-01
• Device Lot Number: 11307817
• Was Device Available for Evaluation?: No
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown