FDA.reportPublic FDA data

MAUDE MDR 8596078

MDR report key
8596078
Report number
2027111-2019-00447
Event key
0
Event type
3
Date of event
2019-04-07
Date received
2019-05-09
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/BXHETAPPLIED MEDICAL RESOURCESHETCB0301014197011345805Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-090

Event Narratives#

N

Patient 1

THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. THIS EVENT IS NOT REPORTABLE AS IT IS UNLIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. THIS REPORT IS IN RESPONSE TO MEDWATCH (B)(4).

D

Patient 1

PROCEDURE PERFORMED: LAP REPAIR OF INCARCERATED L LUMBAR HERNIA. A PLASTIC PIECE BROKE OFF THE HANDLE OF THE SCISSOR DURING SURGERY. THE DEVICE WAS REPLACED AND THE CASE WAS COMPLETED. NO PATIENT INJURY OCCURRED. THE DEVICE IS AVAILABLE FOR RETURN. IT WAS UNKNOWN WHAT WAS OCCURRING AT THE TIME THAT THE UNIT BROKE. LIMITED INFORMATION WAS AVAILABLE. MEDWATCH (B)(4) RECEIVED VIA MAIL ON TUESDAY, 30APR2019: "PLASTIC PIECE BROKE OFF THE HANDLE OF THE LAPAROSCOPIC SCISSORS DURING A LEFT LUMBAR HERNIA PROCEDURE." PATIENT STATUS: NO PATIENT INJURY OCCURRED. TYPE OF INTERVENTION: THE DEVICE WAS REPLACED AND THE CASE WAS COMPLETED.