BIGOPSY BACKLOADING BIOPSY FORCEPS
Received May 28, 2026 · Event occurred Apr 24, 2026
Report 3001845648-2026-00206 · MDR key 25322555
Device
Generic name
Fcl Forceps, Biopsy, Non-electric
Manufacturer
Cook Ireland LtdModel number
G48240Catalog number
BLB-024115
Lot number
C2336356
Product problems
- Difficult to Open or Close
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
G4 - PMA/510 (K) - N/A (CLASS I DEVICE). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
Description of Event or Problem
UROPARTNERS HAD A BIGOPSY FOR BIOPSY IN THE URINARY TRACT TODAY THAT WOULD OPEN, BUT WOULDN'T CLOSE. NO UNINTENDED SECTION OF THIS DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED AND DID NOT UNDERGO PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.