FDA Adverse Event Other Summary report: N

9610617-2008-00032

MDR report key: 1321108 · Received January 2, 2009

Report

Report Number
9610617-2008-00032
Event Type
Other
Date Received
January 2, 2009
Product Code
KOG
Report Source
Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

EVAL STATED THAT DAMAGE (HOLES IN BLOCK, INCORRECT MATERIAL, EPOXY CONNECTION FAILURE-RESEALED AT CONE) WAS DUE TO 3RD PARTY REPAIR AND AGE (17 YEARS OLD) OF INSTRUMENT. THE 27005B/SCOPE BECAME OBSOLETE IN DECEMBER OF 1997 AND WAS REPLACED BY THE 27005BA, AUTOCLAVABLE SCOPE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 KOG

Patients

Seq Age Sex Outcome Treatment
1