MAUDE Adverse Event Report: ARGON MEDICAL DEVICES JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 6F X 50CM MAXI-CURVED; JAWZ BIOPSY FORCEPS

Model Number	190051
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during an endomyocardial biopsy, he believes there was a gap between the shaft and the head of the forceps that caught on the patients valve and pulled some tissue out.There was no patient injury.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded relating to this issue.One opened sample was returned by the customer for review.Upon visual inspection it was found that the blue outer jacket was separated from the spring shaft.The complaint is confirmed.The device would not actuate when received.Distal end of device was soaked for fifteen minutes in alcohol and removed.Device would then slightly start to open upon actuation.Jaw was manipulated open and then the device was soaked again and periodically actuated.After final removal from alcohol soak, the device would actuate.Root cause of the separation of the blue outer jacket from the spring shaft is most likely a foreign substance (organic) caught in the shaft coils causing tension between the distal tip of the jawz and the blue outer jacket.This caused extensive force to be applied to the shaft coils and not to the actual jawz forceps which led to the breakage.A result of the device not being thoroughly rinsed.Since this issue was believed to be caused by the user not thoroughly rinsing with heparinized saline, no corrective action is necessary.The ifu has been updated since the manufacture of this product to further stress the importance of cleaning the device upon removal.There have been no other complaints reported in the lot.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 6F X 50CM MAXI-CURVED
• Common Device Name: JAWZ BIOPSY FORCEPS
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19015724
• Report Number: 0001625425-2024-00974
• Device Sequence Number: 8156494
• Product Code: DWZ
• UDI-Device Identifier: 00886333206742
• UDI-Public: (01)00886333206742(17)281115(10)5624384
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 190051
• Device Lot Number: 5624384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 08/24/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 08/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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: Other
• Patient Sex: Unknown