FDA Adverse Event Malfunction Summary report: N

ELECTRIC SYSTEMS FOOT CONTROL WITH DIR

MDR report key: 7065013 · Received November 28, 2017

Report

Report Number: 1045834-2017-50037
Event Type: Malfunction
Date Received: November 28, 2017
Date of Event: October 26, 2017
Report Date: October 30, 2017
Manufacturer: THE ANSPACH EFFORT LLC
Product Code: HBC
UDI-DI: 00845384011750
PMA / PMN Number: K080802
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND DETERMINED THAT THE CORD WAS DAMAGED AND WIRES WERE EXPOSED PREVENTING THE FUNCTION TEST FROM BEING PERFORMED. IT WAS NOTED THAT THE HOLE IN THE CORD IS DUE TO MISHANDLING OF THE DEVICE BY ALLOWING THE CORD TO COME INTO CONTACT WITH A SHARP OBJECT WHICH PUNCTURED THE CORD OR EXERTING EXTREME FORCE ON THE CORD DURING CLEANING OR USE. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO MISHANDLING WHICH IS USER ERROR. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE FOOT CONTROL DEVICE HAD WIRES EXPOSED. IT WAS NOT REPORTED WHETHER THIS EVENT OCCURRED DURING SURGERY OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
844346	ELECTRIC SYSTEMS FOOT CONTROL WITH DIR	MOTOR, DRILL, ELECTRIC - FOOT CONTROL	HBC	THE ANSPACH EFFORT LLC	E-FP-DIR		00845384011750

Patients

Seq	Age	Sex	Outcome	Treatment
1