inforMED
MalfunctionOCZ

OPTICAL FORCEPS, FOR BIOPSY

Received Sep 23, 2025

Report 9610617-2025-01665 · MDR key 23125646

Device

Generic name

Optical Forceps, For Biopsy

Model number

27072A

Catalog number

27072A

Lot number

OK06

Product problems

  • Break
  • Use of Device Problem
  • Break
  • Use of Device Problem

Patient

NA · Unknown

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

Narrative

Additional Manufacturer Narrative

ACCORDINGLY, WE WOULD LIKE TO GIVE A SUMMARY OF OUR RESULTS REGARDING THE REPORTED ISSUE. DURING THE MANUFACTURER'S TECHNICAL INSPECTION OF THE RETURNED DEVICE, THE ERROR DESCRIPTION PROVIDED BY THE CUSTOMER, "JAWS NOT WORKING, PULL ROD IS BROKEN ", COULD NOT BE CONFIRMED. THROUGH INVESTIGATION NO DEFECTS WERE FOUND. THE FUNCTION OF THE ITEM IS GIVEN. THE INVESTIGATIONS DID NOT REVEAL A ROOT CAUSE RELATED TO THE LABELLING, THE DEVICE, OR ITS HISTORY. ALL PRODUCTION-RELATED QUALITY CHECKS WERE PASSED, AND NO NON-CONFORMITIES WERE IDENTIFIED IN THE DEVICE'S MANUFACTURING RECORDS. THE LABELLING WAS FOUND TO CONTAIN ADEQUATE INSTRUCTIONS AND WARNINGS. THE COMPLAINT HISTORY DID NOT REVEAL ANY PICKUP IN SIMILAR COMPLAINTS; NO TREND WAS IDENTIFIED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO MANUFACTURER. THIS INFORMATION IS REFLECTED IN SECTION D9. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "JAWS NOT WORKING, PULL ROD IS BROKEN". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.