FDA.reportPublic FDA data

MAUDE MDR 9783165

MDR report key
9783165
Report number
2027111-2020-00404
Event key
0
Event type
3
Date of event
2020-01-23
Date received
2020-03-03
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
WENDY KOBAYASHI
Address
22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BXLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)APPLIED MEDICAL RESOURCESHETCB0301014197011366452Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-030

Event Narratives#

N

Patient 1

RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

D

Patient 1

PROCEDURE PERFORMED: LAPAROSCOPIC TOTAL HYSTERECTOMY. ACCORDING TO THE DOCTOR, THE SCISSOR IS BLUNT - IT DIDN'T CUT AT ALL. HE HAD TO OPEN ANOTHER TO FINISH THE PROCEDURE. ADDITIONAL INFORMATION PROVIDED BY PRODUCT SPECIALIST VIA EMAIL 05FEB20: THE SCISSOR WAS BLUNT FROM THE FIRST CUT, THROUGH FAT TISSUE. THE SCISSOR WAS NOT USED TO CUT THROUGH STAPLES, LAP BAND OR DENSE TISSUE. INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: NO PATIENT INJURY.