FDA.reportPublic FDA data

MAUDE MDR 9758123

MDR report key
9758123
Report number
2027111-2020-00385
Event key
0
Event type
3
Date of event
2020-01-30
Date received
2020-02-26
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 RESOURCESHETCB0301014197011360822* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-260

Event Narratives#

N

Patient 1

THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

D

Patient 1

PROCEDURE PERFORMED: LAPAROSCOPIC ILEOANAL POUCH FORMATION. THE REGISTRAR WAS USING THE SCISSORS TO CUT ADHESIONS IN THE ABDOMEN. THE CONSULTANT TOOK OVER THE PROCEDURE AND NOTICED THAT THE SCISSORS WERE BLUNT COMPARED TO USUAL. THE CONSULTANT ASKED FOR THESE TO BE CHANGED FOR FRESH SCISSORS AS A RESULT. THE REGISTRAR THEN SAID THAT THEY HAD BEEN STRUGGLING THROUGH THE CASE WITH THE SCISSORS BEING BLUNT. THE FRESHLY OPENED PAIR OF EPIX SCISSORS WORKED AS USUAL WITH NO PROBLEMS. INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: NO PATIENT INJURY.