PUNCH,BIOPSY,CERV,TISCHLER,ROT,3X7,10"

Description of Event or Problem

ACCORDING TO THE FACILITY, "THE FIRST PAIR OF BIOPSY FORCEPS DID NOT CLOSE ALL THE WAY SO IT DID NOT CLEANLY CUT THROUGH THE TISSUE. WE HAD TO GRAB A SECOND BIOPSY FORCEPS AND TRY AGAIN TO GET A SAMPLE. THIS ONE CLOSED BUT IT STUCK SO WE HAD TO PRY THIS ONE OPEN".

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY, "THE FIRST PAIR OF BIOPSY FORCEPS DID NOT CLOSE ALL THE WAY SO IT DID NOT CLEANLY CUT THROUGH THE TISSUE. WE HAD TO GRAB A SECOND BIOPSY FORCEPS AND TRY AGAIN TO GET A SAMPLE. THIS ONE CLOSED BUT IT STUCK SO WE HAD TO PRY THIS ONE OPEN. THERE WAS INCREASED BLEEDING DUE TO THE MULTIPLE TRAUMA'S. WE WERE ABLE TO CONTROL IT WITH OUR NORMAL INTERVENTION BUT THERE WAS MORE TRAUMA THAN WAS NECESSARY". IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Additional Manufacturer Narrative

UPDATE D6- RETURNED TO MANUFACTURER SAMPLE RECEIVED 12/10/2025. UPDATE H3- YES. UPDATE H6- B- TESTING OF ACTUAL/SUSPECTED DEVICE.