MalfunctionGZX

SYNERGETICS

Received Oct 13, 2023 · Event occurred Sep 8, 2023

Report 17930178 · MDR key 17930178

Device

Generic name

Instrument, Microsurgical

Manufacturer

Synergetics ,inc.

Model number

20.04.25S

Catalog number

20.04.25S

Lot number

M0049344

Patient

25185 DA · Female

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

25GA TANO DIAMOND DUSTED MEMBRANE SCRAPPER (DDMS) TIP BROKE OFF INSIDE PATIENT'S RIGHT EYE. SURGEON COULD NOT REMOVE IT THROUGH THE 25GA CANNULA. SURGEON REMOVED THE 25GA CANNULA, OPENED CONJUNCTIVA WITH WESTCOTTS, MADE 20GA SCLERA INCISION WITH MVR BLADE. REMOVED BROKEN TIP USING ILM FORCEPS. CLOSED SCLERAL INCISION WITH 7-0 VICRYL SUTURE. CLOSED CONJUNCTIVA WITH 6-0 PLAIN GUT SUTURE.