FDA Adverse Event Malfunction Summary report: N

DREAMTOME¿ RX 44

MDR report key: 7733455 · Received July 30, 2018

Report

Report Number: 3005099803-2018-02507
Event Type: Malfunction
Date Received: July 30, 2018
Report Date: October 1, 2018
Product Code: KNS
PMA / PMN Number: K013153
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOR THE EVENTS RELATED TO E 2012064, 25 DEVICES WERE RETURNED AND EVALUATED. ALL 25 WERE IDENTIFIED TO HAVE A ROOT CAUSE OF OPERATIONAL CONTEXT. 24 DEVICES WERE DISPOSED AND WILL NOT BE AVAILABLE FOR EVALUATION. INVESTIGATION IS STILL IN PLACE FOR 2 EVENTS. CONCLUSION CODE 4316 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR "DEVICE NOT RETURNED" FOR ALL RELEVANT EVENTS.

Additional Manufacturer Narrative · 1

2018-Q3 SUPPLEMENT_2018-Q2 EXEMPTION E2012064_SUBMISSION_KNS, 2018-Q3 SUPPLEMENT_2018-Q1 EXEMPTION E2012064_SUBMISSION_KNS.

Description of Event or Problem · 1

THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2012064 FOR PRODUCT CODE KNS. THIS REPORT COVERS 47 REPORTED EVENTS OF TOME WIRE BREAKS AND 5 EVENTS OF NEEDLE KNIFE NEEDLE BREAK. OF THE EVENTS, 9 PATIENTS WERE FEMALE AND 1 WAS MALE. THE KNOWN PATIENTS' AGES RANGED FROM 48 YEARS TO 80 YEARS. THE KNOWN PATIENTS' WEIGHTS RANGED FROM 50 KG TO 60 KG. ALL OTHER DEMOGRAPHIC INFORMATION IS UNKNOWN.

Description of Event or Problem · 1

THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2012064 FOR PRODUCT CODE KNS. QUARTERLY SUBMISSION DUE OCTOBER 31, 2018. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR 3 EVENTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
573164	DREAMTOME¿ RX 44	UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)	KNS		M00584040

Patients

Seq	Age	Sex	Outcome	Treatment
1