UROVAC BLADDER EVACUATOR
Received May 5, 2025 · Event occurred Apr 8, 2025
Report 2124215-2025-28566 · MDR key 21965104
Device
Generic name
Evacuator, Bladder, Manually Operated
Manufacturer
Boston Scientific CorporationModel number
M0067301251Catalog number
730-125
Lot number
0035954603
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A UROVAC DEVICE WAS ABOUT TO BE USED DURING TURP (TRANSURETHRAL RESECTION OF THE PROSTATE) PROCEDURE. REPORTEDLY, UPON OPENING THE PACKAGING THEY SAW A BLACK FLECKS INSIDE THREE UROVACS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE THIRD OF THREE UROVAC DEVICES USED IN THE SAME PROCEDURE.
Additional Manufacturer Narrative
DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF FOREIGN MATERIAL PRESENT IN THE DEVICE.