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

Model Number 190051

Device Problems Failure to Obtain Sample (2533); Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

Sample is indicated as returned.As of the date of this report, sample has not been evaluated yet.A follow-up report will be submitted once the sample has been reviewed.

Event Description

Jawz forceps would not open to obtain a bx specimen.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.Ifu under precautions- "the forcep should be thoroughly rinsed with heparinized saline prior to each specimen collection during the procedure." one opened device was returned for evaluation.Device one 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 device not working properly is most likely a foreign substance(organic) caught in the clevis area mechanism of the distal tip(jawz).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.

Event Description

Jawz forceps would not open to obtain a bx specimen.

• Brand Name: JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 6F X 50CM MAXI-CURVED
• Type of Device: 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: 15741052
• MDR Text Key: 307198942
• Report Number: 0001625425-2022-01123
• Device Sequence Number: 1
• Product Code: DWZ
• UDI-Device Identifier: 00886333206742
• UDI-Public: 00886333206742
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 190051
• Device Catalogue Number: 190051
• Device Lot Number: 5081669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other