STONETOME¿

Report

• Report Number: 3005099803-2018-02508
• Event Type: Malfunction
• Date Received: July 30, 2018
• Report Date: July 1, 2018
• Product Code: LQR
• PMA / PMN Number: K946358
• Report Source: Manufacturer report
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOR THE EVENTS RELATED TO E 2012065, ALL 4 DEVICES WERE RETURNED AND EVALUATED. ALL 4 WERE IDENTIFIED TO HAVE A ROOT CAUSE OF OPERATIONAL CONTEXT.

Description of Event or Problem · 1

THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2012065 FOR PRODUCT CODE LQR. THIS REPORT COVERS 4 REPORTED EVENTS OF TOME WIRE BREAKS. OF THE EVENTS, ONE OF THE PATIENTS WAS MALE. ALL OTHER DEMOGRAPHIC INFORMATION IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
572420	STONETOME¿	DISLODGER, STONE, BILIARY	LQR		M00535110

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Consequences Or Impact To Patient

Product problems · 1

• Break

Type of report · 1

• Initial submission