FDA.reportPublic FDA data

MAUDE MDR 7232638

MDR report key
7232638
Report number
9610612-2018-00040
Event key
0
Event type
3
Date of event
2017-12-29
Date received
2018-01-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. NICOLE BROYLES
Address
615 LAMBERT POINTE DRIVE HAZELWOOD MO 63042 US
Phone
314-314-3145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IRIS SCISSORS CVD S/S 110MMSURGICAL SCISSORSAESCULAP AGHNFBC111RBC111R4508119663Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-3101. O

Event Narratives#

N

Patient 1

(B)(4). MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

D

Patient 1

COUNTRY OF COMPLAINT: (B)(6). DURING PROCEDURE, THE TIP OF BLADE WAS BROKEN. THE BREAKAGE WAS FOUND (B)(6) 2018. THE CUSTOMER WAS NOT SURE THAT THE BREAKAGE WAS CAUSED DURING MAINTENANCE OR PROCEDURE AT THE TIME OF FINDING THE BREAKAGE. AS THERE WAS THE POSSIBILITY OF REMAINING INSIDE A PATIENT, THE CUSTOMER CHECKED AND FOUND THAT THE BROKEN TIP WAS INSIDE THE PATIENT WHO HAD PTOSIS SURGERY ON (B)(6) 2017. ACCORDING TO X-RAY, THE BROKEN TIP WAS AROUND ORBIT. THE SURGERY TO REMOVE THE BROKEN TIP IS SCHEDULED (B)(6) 2018.