JAWZ ENDOMYOCARDIAL BIOPSY FORCEP 6F X 105CM STRAIGHT
Received Apr 25, 2022 · Event occurred Feb 18, 2022
Report 0001625425-2022-00994 · MDR key 14198960
Device
Generic name
Jawz Endomyocardial Biopsy Forcep
Manufacturer
Argon Medical DevicesModel number
190075Catalog number
190075
Lot number
5156033
Product problems
- Break
- Detachment of Device or Device Component
- Physical Resistance/Sticking
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional 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.
Description of Event or Problem
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.
Description of Event or Problem
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.
Additional 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.