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

Model Number 190075

Device Problems Break (1069); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

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

Event Date 02/18/2022

Event Type  malfunction  

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 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 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.

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
• 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: 14198960
• MDR Text Key: 295899345
• Report Number: 0001625425-2022-00994
• Device Sequence Number: 1
• Product Code: DWZ
• UDI-Device Identifier: 00886333206803
• UDI-Public: 00886333206803
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other