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

Model Number	190075
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
During procedure, a physician stopped using the jawz as the jaws couldn't open/close in body.As a result of the returned sample(s) review at gmkk: unable to manipulate the jaws due to the broken handle.Detached core wire from the handle was found.
Event or Problem Description
During procedure, a physician stopped using the jawz as the jaws couldn't open/close in body as a result of the returned sample(s) review at gmkk: unable to manipulate the jaws due to the broken handle.Detached core wire from the handle was found.
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.No sample was returned for evaluation, however images were provided.Upon viewing the images it was found that the actuating wire had come out of the ferrule used to hold it under the grub screw.Thereby confirming the complaint.A scar# scar-00026 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 FORCEP 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: 14198960
• Report Number: 0001625425-2022-00994
• Device Sequence Number: 5245934
• Product Code: DWZ
• UDI-Device Identifier: 00886333206803
• UDI-Public: 00886333206803
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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: 07/31/2026
• Device Model Number: 190075
• Device Catalogue Number: 190075
• Device Lot Number: 5156033
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Supplement Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 06/21/2022
• 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