FDA.reportPublic FDA data

MAUDE MDR 8617805

MDR report key
8617805
Report number
2027111-2019-00452
Event key
0
Event type
3
Date of event
2019-04-17
Date received
2019-05-16
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
1C4140, 5MMX45CM EPIX LAPA GRASPER, 10/BXLAPAROSCOPIC ACCESSORIES, GYNECOLOGICAPPLIED MEDICAL RESOURCESNWVC41401009154021344710Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-160

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: ROBOTIC REPAIR OF INCARCERATED HERNIA WITH MESH THE SURGEON WAS TAKING DOWN THE UMBILICAL HERNIA AND WAS PULLING ON TISSUE WITH THE GRASPER WHEN IT BENT PAST THE JAWS. THE SURGEON COULD NOT OPEN THE JAWS STILL ATTACHED TO THE TISSUE SO THE JAWS WERE JUST PULLED OFF THE TISSUE. WHEN THE UNIT WAS REMOVED FROM THE TROCAR THE SHAFT BROKE COMPLETELY. ALL MATERIALS WERE RETRIEVED FROM THE PATIENT. THIS OCCURRED AT THE BEGINNING OF THE CASE. THE ROBOT WAS NOT DOCKED YET. NO PATIENT INJURY OCCURRED. THE CASE WAS CONTINUED AFTER REMOVAL OF THE UNIT. IT IS UNKNOWN IF THE DEVICE WAS REPLACED. A PICTURE IS AVAILABLE. THE PATIENT IS STABLE. NO PATIENT DEMOGRAPHICS WERE AVAILABLE. PATIENT STATUS: NO INJURY, PATIENT IS STABLE. TYPE OF INTERVENTION: THE UNIT WAS REMOVED AND ALL PIECES WERE RETRIEVED FROM THE PATIENT.