inforMED
MalfunctionDWH

POWERPRO BATTERY RECIPROCATING SAW

Received Jul 10, 2007 · Event occurred Jun 28, 2007

Report 1017294-2007-00460 · MDR key 879835

Device

Generic name

Powerpro Battery System

Manufacturer

Conmed Linvatec

Model number

NA

Catalog number

PRO5400

Lot number

NA

Product problems

  • Device Inoperable

Patient

YR

  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: THE HANDPIECE WAS RECEIVED FOR EVALUATION AND DURING TESTING WAS FOUND TO HAVE THE POTENTIAL TO OPERATE ON ITS OWN RELATED TO CONTROLLER FAILURE. AN INVESTIGATION FOR THIS FAILURE MODE REMAINS IN PROCESS. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS PRODUCT FOR FAILURES. THERE ARE NO REPORTED INJURIES RELATED TO THIS FAILURE MODE.

Description of Event or Problem

THIS HANDPIECE WAS RETURNED WITH THE REPORT THAT IT WOULD NOT OPERATE. THERE ARE NO INJURIES OR DELAYS RELATED TO THIS EVENT.