MalfunctionDWZ
JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 7.5F X 50CM PRE-CURVED
Received Mar 24, 2022 · Event occurred Feb 23, 2022
Report 0001625425-2022-00970 · MDR key 13891727
Device
Generic name
Jawz Endomyocardial Biopsy Forcep
Manufacturer
Argon Medical DevicesModel number
190030Catalog number
190030
Lot number
5180239
Product problems
- Break
- Difficult to Remove
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional 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.
Description of Event or Problem
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.