FDA.reportPublic FDA data

MAUDE MDR 3212341

MDR report key
3212341
Report number
2523190-2013-00044
Event key
0
Event type
3
Date of event
2013-06-07
Date received
2013-07-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
SANDRA LEE
Address
315 ENTERPRISE DR
Phone
609-609-6099
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COHEN INTRAUTERINE PROBENAINTEGRA YORK, PA INC.HCZ505230UNKNOWN* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-07-020

Event Narratives#

D

Patient 1

MEDWATCH #(B)(4) WAS RECEIVED ON (B)(6) 2013 STATING THAT; PATIENT WAS DISCHARGED HOME AFTER AN OUTPATIENT LAPAROSCOPIC/GYNECOLOGICAL PROCEDURE. PATIENT WAS TRYING TO VOID WHEN A "LARGE METAL OBJECT" CAME OUT OF HER VAGINA. SHE REPORTED THIS TO HER SURGEON WHO IDENTIFIED THE OBJECT AS THE CERVICAL CONE PORTION OF A COHEN ACORN CANNULA. THE CONE WAS INADVERTENTLY LEFT INSIDE THE VAGINA UPON REMOVAL OF THE CANNULA. THE CERVICAL CONE PORTION OF THE DEVICE SCREWS ONTO THE DISTAL END OF THE CANNULA AND WAS ASSUMED TO BE LOOSE UPON REMOVAL. NEITHER SURGEON NOR THE SURGICAL TECH NOTICED IT WAS MISSING UPON REMOVAL. ON (B)(6) 2013 CUSTOMER REPORTS THE DEVICE WAS EXPELLED THE SAME DAY AS SURGERY, NO HARM DONE TO THE PATIENT.

N

Patient 1

TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.