FDA.reportPublic FDA data

MAUDE MDR 9632350

MDR report key
9632350
Report number
3011137372-2020-00049
Event key
0
Event type
3
Date of event
2019-12-13
Date received
2020-01-27
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
JASMINE BROWN
Address
3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US
Phone
919-919-9193
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MAYO SCISSORS CVD 6 3/4" BEVSCISSORS, GENERAL, SURGICALTELEFLEX MEDICALLRW141317XX8R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-2701. R

Event Narratives#

N

Patient 1

(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

D

Patient 1

IT WAS REPORTED THAT THE SURGEON WAS DOING A HIP SURGERY AND WAS CUTTING NEAR THE FASCIA AROUND ACETABULUM AND THE NEXT THING THE SCISSORS WERE IN THREE PIECES PER THE SCRUB NURSE. THEY THEN STOPPED THE SURGERY, DID AN X-RAY, AND THEN GENERAL SURGERY REMOVED THE PIECE STILL IN PATIENT.