inforMED
MalfunctionGEI

MONOPOLAR CABLE, ELECTROSURGICAL ACCESSORIES

Received Jun 22, 2004

Report 9614969-2004-00002 · MDR key 3546056

Device

Generic name

Endoscopic Instrument

Product problems

  • Thermal Decomposition of Device
  • Component Falling
  • Fire
  • Failure to Power Up
  • Split
  • Sparking

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

PLEASE REFER IMPORTER REPORT # (B)(4).

Additional Manufacturer Narrative

INTEGRA LIFESCIENCES CORPORATION IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR (B)(4). CORRESPONDENCE AND INQUIRIES SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORPORATION, (B)(4).