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

Model Number	190065
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as returned.As of this date, the sample has not been reviewed.A follow-up report will be submitted once the sample has been reviewed.
Event or Problem Description
During procedure, a physician stopped using the jawz as the jaws action(open/close) was slow in response to the manipulation.The jawz was replaced with an additionally opened 190065, and the procedure was completed.As a result of the returned sample(s) review at (b)(6): the jaws action(open/close) was slow response with some resistance, when it was in curved situation.
Event or Problem Description
During procedure, a physician stopped using the jaws as the jaws action(open/close) was slow in response to the manipulation.The jaws was replaced with an additionally opened 190065, and the procedure was completed.As a result of the returned sample(s) review at gmkk: the jaws action(open/close) was slow response with some resistance, when it was in curved situation.
Additional 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.Visual inspection found no damage to the device.The device was functionally tested and found to actuate slower than designed.The complaint was confirmed.Since the device was returned opened a root cause could not be determined with confidence.Root cause of the device not working properly could possibly be foreign substance(organic) caught in the clevis area mechanism of the distal tip(jaws).A result of the device not being thoroughly rinsed.Since this issue could have been 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.

• Brand Name: JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 6F X 50CM STRAIGHT
• Common Device Name: JAWZ
• 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: 15445742
• Report Number: 0001625425-2022-01088
• Device Sequence Number: 20713506
• Product Code: DWZ
• UDI-Device Identifier: 00886333206773
• UDI-Public: 00886333206773
• 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): 09/26/2022

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: 09/30/2026
• Device Model Number: 190065
• Device Catalogue Number: 190065
• Device Lot Number: 5186631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• 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: 09/02/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 09/26/2022
• 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