FDA.reportPublic FDA data

MAUDE MDR 9581097

MDR report key
9581097
Report number
3003398873-2020-00008
Event key
0
Event type
3
Date of event
2019-12-26
Date received
2020-01-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JONATHAN SCHLECH
Address
6201 SOUTH FREEWAY MAIL STOP AB2-6 FORT WORTH TX 76134 US
Phone
817-817-8175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GRIESHABER REVOLUTION DSP SCISSORSSCISSORS, OPHTHALMICALCON GRIESHABER AGHNFNA706.52F172769R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-130

Event Narratives#

N

Patient 1

NO SAMPLE HAS BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. 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).

D

Patient 1

A NURSE REPORTED THAT AN OPHTHALMIC SCISSORS TIP BROKE AND SEPARATED WHILE INSIDE OF THE PATIENT'S EYE DURING SURGERY. AN ALTERNATE DEVICE WAS OBTAINED IN ORDER TO RETRIEVE THE BROKEN SCISSORS PART FROM THE EYE. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED FURTHER CLARIFIED THAT AN ENLARGED INCISION WAS CREATED IN ORDER TO SUCCESSFULLY REMOVE THE BROKEN SCISSORS PART FROM THE PATIENT'S EYE. THE PROCEDURE BEING PERFORMED WAS A VITRECTOMY. AN ALTERNATE, THIRD SCISSORS TIP WAS OBTAINED IN ORDER TO SUCCESSFULLY COMPLETE THE PROCEDURE.