JAWZ ENDOMYOCARDIAL BIOPSY FORCEP 6F X 105CM STRAIGHT
Received Dec 23, 2021 · Event occurred Nov 22, 2021
Report 0001625425-2021-01234 · MDR key 13082403
Device
Generic name
Jawz
Manufacturer
Argon Medical DevicesModel number
190075Catalog number
190075
Lot number
5128344
Product problems
- Difficult to Open or Close
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
DURING PROCEDURE, A PHYSICIAN STOPPED USING THE JAWZ AS THE JAWS DIDN'T OPEN IN BODY. THE JAWZ WAS REPLACED WITH AN ADDITIONALLY OPENED 190075, AND THE PROCEDURE WAS COMPLETED. AS A RESULT OF THE RETURNED SAMPLE(S) REVIEW AT (B)(4): THERE WAS SOME RESISTANCE IN THE MANIPULATION TO OPEN THE JAWS, THEN THE JAWS OPENED WITH SLOW RESPONSE.
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.
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. ONE OPENED DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND NO DAMAGE TO THE PRODUCT. FUNCTIONALLY, THE DEVICE WOULD EITHER NOT OPEN OR OPEN SLOWLY, THEN SUDDENLY SNAP OPEN. A MAGNIFIED VIEW FOUND THAT ONE OF THE PINS IN THE CLEVIS MECHANISM MAY HAVE BEEN OVER PRESSED, CAUSING AN INTERMITTENT DRAG WHEN TRYING TO ACTUATE THE DEVICE. THE SAMPLES ARE BEING SENT BACK TO THE SUPPLIER FOR FURTHER INVESTIGATION. A SCAR# S-2020-00006 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.
Description of Event or Problem
DURING PROCEDURE, A PHYSICIAN STOPPED USING THE JAWZ AS THE JAWS DIDN'T OPEN IN BODY. THE JAWZ WAS REPLACED WITH AN ADDITIONALLY OPENED 190075, AND THE PROCEDURE WAS COMPLETED. AS A RESULT OF THE RETURNED SAMPLE(S) REVIEW AT GMKK: THERE WAS SOME RESISTANCE IN THE MANIPULATION TO OPEN THE JAWS, THEN THE JAWS OPENED WITH SLOW RESPONSE.
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. ONE OPENED DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND NO DAMAGE TO THE PRODUCT. FUNCTIONALLY, THE DEVICE WOULD EITHER NOT OPEN OR OPEN SLOWLY, THEN SUDDENLY SNAP OPEN. A MAGNIFIED VIEW FOUND THAT ONE OF THE PINS IN THE CLEVIS MECHANISM MAY HAVE BEEN OVER PRESSED, CAUSING AN INTERMITTENT DRAG WHEN TRYING TO ACTUATE THE DEVICE. THE SAMPLES ARE BEING SENT BACK TO THE SUPPLIER FOR FURTHER INVESTIGATION. A SCAR 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.
Description of Event or Problem
DURING PROCEDURE, A PHYSICIAN STOPPED USING THE JAWZ AS THE JAWS DIDN'T OPEN IN BODY. THE JAWZ WAS REPLACED WITH AN ADDITIONALLY OPENED 190075, AND THE PROCEDURE WAS COMPLETED. AS A RESULT OF THE RETURNED SAMPLE(S) REVIEW AT GMKK: THERE WAS SOME RESISTANCE IN THE MANIPULATION TO OPEN THE JAWS, THEN THE JAWS OPENED WITH SLOW RESPONSE.