Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 7.5F X 50CM PRE-CURVED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARGON MEDICAL DEVICES JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 7.5F X 50CM PRE-CURVED Back to Search Results
Model Number 190030
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2022
Event Type  malfunction  
Manufacturer Narrative
As of the date of this report, the sample has not been returned and evaluated.If additional information is provided in the future, a follow-up report will be submitted.
 
Event Description
During routine rv biopsy, the forcep spring snapped causing difficulty to retrieve forcep from patient.Ultimately it was retrieved using a hemostat.No harm was done to patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 7.5F X 50CM PRE-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 Key13891727
MDR Text Key295899715
Report Number0001625425-2022-00970
Device Sequence Number1
Product Code DWZ
UDI-Device Identifier00886333206711
UDI-Public00886333206711
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K951447
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number190030
Device Catalogue Number190030
Device Lot Number5180239
Was the Report Sent to FDA? No
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
-
-