inforMED
MalfunctionHNR

GRIESHABER REVOLUTION DSP FORCEPS

Received Jul 20, 2026 · Event occurred Jun 24, 2026

Report 3003398873-2026-00149 · MDR key 25871538

Device

Generic name

Forceps, Ophthalmic

Model number

NA

Catalog number

705.44P

Lot number

17L613

Product problems

  • Activation Problem

Patient

NA · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A PHYSICIAN REPORTED THAT THE TIP OF THE OPHTHALMIC FORCEPS DID NOT OPEN PROPERLY, AND THE INTERNAL LIMITING MEMBRANE WAS NOT WELL GRASPED DURING SURGERY ON THE LEFT EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND THERE WAS NO PATIENT HARM.