MalfunctionDWZ
JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS
Received May 12, 2023 · Event occurred Mar 27, 2023
Report 16918659 · MDR key 16918659
Device
Generic name
Device, Biopsy, Endomyocardial
Manufacturer
Argon Medical Devices, Inc.Model number
190085Catalog number
190085
Lot number
5428636
Product problems
- Failure to Obtain Sample
Patient
17885 DA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PHYSICIAN UNABLE TO OBTAIN ANY MYOCARDIAL BIOPSY TISSUE SAMPLES WITH THE CURRENT FORCEPS. ONCE THIS WAS TAKEN OUT OF SERVICE AND A NEW FORCEPS USED, THEN PHYSICIAN WAS ABLE TO OBTAIN SAMPLE IMMEDIATELY WITHOUT DIFFICULTY.