FDA Adverse Event Malfunction Summary report: N

ACCY EF201 IPC FOOT CONTROL ROHS

MDR report key: 4073381 · Received September 9, 2014

Report

Report Number: 1045254-2014-00217
Event Type: Malfunction
Date Received: September 9, 2014
Date of Event: August 15, 2014
Report Date: August 15, 2014
Manufacturer: MEDTRONIC XOMED INC.
Product Code: HBE
PMA / PMN Number: K081475
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONSOLE 1898001 IPC, 510K: K081277, SERIAL # (B)(4), LOT# 68637100, MFR DATE: 2010-07-15 (B)(4). THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. METHOD: NO TESTING METHODS PERFORMED. (B)(4).

Additional Manufacturer Narrative · 1

THE DEVICES WERE RETURNED SEPT. 10, 2014. THE DEVICES WERE EVALUATED SEPT. 25, 2014. THE CUSTOMER¿S COMPLAINT COULD NOT BE DUPLICATED. THE PRODUCT ANALYSIS FOR (B)(4) (IPC CONSOLE) FOUND A SCRATCHED BACK HOUSING, BUT NO OTHER FAULT WAS FOUND. PRODUCT ANALYSIS FOR EF201 (FOOT CONTROL) FOUND NO FAULT; THE DEVICE OPERATED WITHIN SPECIFICATION. (B)(4)

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A POSTERIOR CERVICAL PROCEDURE, THE DRILL STARTED RUNNING AT 40,000 RPM WHEN FOOT PEDAL WAS NOT DEPRESSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CONSOLE. THERE WAS NO PATIENT IMPACT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
555857	ACCY EF201 IPC FOOT CONTROL ROHS	DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)	HBE	MEDTRONIC XOMED INC.	EF201	208420257

Patients

Seq	Age	Sex	Outcome	Treatment
1