inforMED
MalfunctionOCZ

BIOPSY FORCEPS, FLEXIBLE, 3 FR.

Received Aug 14, 2025

Report 9610617-2025-01413 · MDR key 22806542

Device

Generic name

Biopsy Forceps, Flexible, 3 Fr.

Model number

11275ZE

Catalog number

11275ZE

Lot number

SL01

Product problems

  • Use of Device Problem
  • Mechanical Jam
  • Mechanical Jam

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE DEVICE WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE FORCEPS NO LONGER CAN BE OPENED DURING PROCEDURE. THE PROCEDURE WAS NOT SUCCESSFULLY FINISHED SINCE THE SURGEON WAS NOT ABLE TO REMOVE ALL THE SAMPLES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.