MalfunctionHMF
MCPHERSONS ROTATOR
Received Sep 21, 2018 · Event occurred May 2, 2018
Report 0001920664-2018-00127 · MDR key 7899314
Device
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE HOSPITAL REPORTED THAT THE INSTRUMENT INVOLVED IN THIS EVENT WAS FROM "(B)(4)". HOWEVER, THE REVIEW OF OUR RECORDS, SYSTEMS AND CATALOGS DID NOT FIND ANY INFORMATION REGARDING THE MANUFACTURING OF THIS INSTRUMENT. WE ARE REPORTING THIS EVENT BASE ON THE INFORMATION PROVIDED IN THE REPORT BY THE (B)(6).
Description of Event or Problem
WE WERE NOTIFIED BY THE (B)(6) OF AN INCIDENT REPORTED TO THEM BY (B)(6) HOSPITAL IN (B)(6). THE REPORT STATED THAT WHILE THE INSTRUMENT WAS BEING USED, A SMALL PART OF THE TIP BROKE OFF IN THE PATIENT'S EYE. THERE WAS NO INJURY TO THE PATIENT.