FDA Adverse Event Malfunction Summary report: N

VASOVIEW HEMOPRO EVH SYSTEM

MDR report key: 1935517 · Received November 10, 2010

Report

Report Number: 2242352-2010-03272
Event Type: Malfunction
Date Received: November 10, 2010
Date of Event: October 11, 2010
Report Date: November 5, 2010
Manufacturer: MAQUET CARDIOVASCULAR, LLC
Product Code: GEI
PMA / PMN Number: K052274
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE DISSECTION TIP WAS RECEIVED AS A COMPLETE ASSEMBLY. THERE WAS SOME BLOOD ON THE CONNECTING SURFACES OF THE TWO COMPONENTS OF THE TIP. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "TIP FOGGING UP" WAS CONFIRMED SINCE THERE WAS FLUID IN THE TIP THAT COULD HAVE AFFECTED THE IMAGE QUALITY. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

Description of Event or Problem · 1

THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE AND DURING INITIAL VEIN AND TISSUE DISSECTION, IT WAS NOTED THE DISSECTION TIP ON THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM BECAME INCREASINGLY "FOGGED OR STEAMED." THERE WERE SEVERAL ATTEMPTS AT CLEANING THE TIP AS WELL AS THE END OF THE SCOPE. THE HARVESTER OBTAINED A NEW KIT, REPLACED THE DISSECTION TIP AND PROCEEDED WITHOUT INCIDENT. THE CASE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO HARM OR INJURY TO THE PT. THE PRODUCT WAS RETURNED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VASOVIEW HEMOPRO EVH SYSTEM	ENDOSCOPIC VESSEL HARVESTING SYSTEM	GEI	MAQUET CARDIOVASCULAR, LLC	VH-3000	25020227

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA