FDA.reportPublic FDA data

MAUDE MDR 8209860

MDR report key
8209860
Report number
2028159-2019-00004
Event key
0
Event type
3
Date of event
2018-12-03
Date received
2019-01-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CINDY MILAM
Address
6201 SOUTH FREEWAY MAIL STOP AB2-6 FORT WORTH TX 76134 US
Phone
817-817-8176
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LASER PROBESINSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWEREDALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTERHQENA806575111418021067XY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-020

Event Narratives#

N

Patient 1

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 CUSTOMER REPORTED THAT DURING SURGERY, THE LASER PROBE TIP STUCK IN THE MIDDLE OF THE TROCAR AND COULD NOT BE ADVANCED FORWARD. THE SURGERY WAS COMPLETED AFTER REPLACING THE PROBE AND TROCAR. THERE WAS NO PATIENT HARM.