MAUDE Adverse Event Report: ARGON MEDICAL DEVICES JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 6F X 105CM STRAIGHT

Model Number	190070
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital used endomyocardial biopsy forceps to sample myocardial tissue for patients on (b)(6) 2022.During the operation, the patient has been locally anesthetized, and after many times of triggering, the myocardial biopsy forceps are still unable to obtain tissue (the jaws cannot be opened).Experts on the stage repeatedly confirmed that it was a quality problem of myocardial biopsy forceps, and then exchanged a new myocardial biopsy forceps and successfully removed the tissue.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
The hospital used endomyocardial biopsy forceps to sample myocardial tissue for patients on (b)(6) 2022.During the operation, the patient has been locally anesthetized, and after many times of triggering, the myocardial biopsy forceps are still unable to obtain tissue (the jaws cannot be opened).Experts on the stage repeatedly confirmed that it was a quality problem of myocardial biopsy forceps, and then exchanged a new myocardial biopsy forceps and successfully removed the tissue.
Additional Manufacturer Narrative
A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.One opened device was returned for evaluation.Visual inspection found no damage to the product.Functionally, the device would either not open or open slowly, then suddenly snap open.A magnified view found that one of the pins in the clevis mechanism may have been over pressed, causing an intermittent drag when trying to actuate the device.The samples are being sent back to the supplier for further investigation.A scar# s-2020-00006 has been issued to notify the supplier viant as&o holdings, llc that an investigation is necessary.Per the supplier's investigation, they will take necessary corrective measures.

• Brand Name: JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 6F X 105CM STRAIGHT
• Common Device Name: JAWZ ENDOMYOCARDIAL BIOPSY FORCEP
• 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: 15224503
• Report Number: 0001625425-2022-01059
• Device Sequence Number: 5978081
• Product Code: DWZ
• UDI-Device Identifier: 00886333206797
• UDI-Public: 00886333206797
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951447
• 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): 09/06/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: 190070
• Device Catalogue Number: 190070
• Device Lot Number: 5052393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/06/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown