FDA.reportPublic FDA data

MAUDE MDR 8418792

MDR report key
8418792
Report number
9610612-2019-00175
Event key
0
Event type
3
Date received
2019-03-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LINDSAY CHROMIAK
Address
3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US
Phone
314-314-3145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VALVE XS DISS.SCISSORS 15?CVD.235/370MMSPECIALITIES CARDIO-THORACIC SAESCULAP AGLRWFC265RFC265R52322113N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-130

Event Narratives#

N

Patient 1

(B)(4). IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED THE SCISSORS MALFUNCTIONED INTRAOPERATIVELY. DURING A MINIMALLY INVASIVE CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE, WHILE USING A PAIR OF SCISSORS THE BLADES STARTED CROSSING TOO FAR AND WOULD GET STUCK. PER THE REPORTER, BOTH BLADES FALL TO THE SIDE OCCASIONALLY AS YOU OPERATE THE SCISSORS. A SECOND PARIF OF SCISSORS WERE USED, WHICH DEMONSTRATED THE SAME ISSUE. THE SURGERY WAS REPORTED TO HAVE TAKEN A LITTLE LONGER DUE TO OBTAINING A THIRD PAIR OF SCISSORS FROM A DIFFERENT COMPANY TO FINISH THE CASE. NO HARM WAS DONE TO THE PATIENT. NO OTHER INFORMATION HAS BEEN PROVIDED. ASSOCIATED MEDWATCHES: 9610612-2019-00176.