FDA Adverse Event Injury Summary report: N

J-UMIL-050037; UMI-LOC LOCKABLE UTERINE MANIPULATOR INJECTOR

MDR report key: 5006564 · Received August 7, 2015

Report

Report Number: 1833117-2015-00002
Event Type: Injury
Date Received: August 7, 2015
Report Date: August 5, 2015
Manufacturer: CATHETER RESEARCH, INC.
Product Code: LKF
PMA / PMN Number: K974357
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE USED DURING THE PROCEDURE WAS RETURNED ALONG WITH 5 UNUSED DEVICES. THE EVAL (BOTH VISUAL AND FUNCTIONAL) OF THE RETURNED UNITS SHOWS NO DEFECT FROM THE DEVICE THAT COULD CONTRIBUTE TO THE PERFORATION OF THE UTERUS DURING INSERTION. THE IFU CLEARLY ALERTS THE USER OF POTENTIAL PERFORATION OF THE UTERUS WITH THIS DEVICE WHEN EXCESSIVE FORCE IS USED DURING THE PROCEDURE. IFU EXCERPT: "WARNING: EXCESSIVE FORCE IN MANIPULATION MAY RESULT IN UTERINE PERFORATION OR MAY CAUSE THE PRODUCT TO BEND OR BREAK, RESULTING IN UTERINE OR VAGINAL TRAUMA. WARNING: NEGLECTING TO SECURELY ATTACH OR LOCK THE HANDLE AT THE CORRECT SOUNDED DEPTH MAY RESULT IN UTERINE TRAUMA DURING MANIPULATION".

Description of Event or Problem · 1

ON INSERTION OF THE PRODUCT, THE UTERUS WAS PERFORATED. THIS HAPPENS ON 3 DIFFERENT OCCASIONS INVOLVING 2 DIFFERENT OPERATORS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
521259	J-UMIL-050037; UMI-LOC LOCKABLE UTERINE MANIPULATOR INJECTOR	UTERINE MANIPULATOR/INJECTOR	LKF	CATHETER RESEARCH, INC.	UMI-LOC	K273

Patients

Seq	Age	Sex	Outcome	Treatment
1	36 YR		Required Intervention