FDA Adverse Event Other Summary report: N

OLYMPUS LAB AUTOMATION SYSTEM

MDR report key: 964616 · Received December 10, 2007

Report

Report Number: 3004148966-2007-00001
Event Type: Other
Date Received: December 10, 2007
Date of Event: November 7, 2007
Report Date: December 10, 2007
Manufacturer: OLYMPUS DIAGNOSTICA LAB AUTOMATION GMBH
Product Code: JQP
PMA / PMN Number: EXEMPT
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION OF THE AFFECTED SYSTEM DID NOT INDICATE SHARP EDGES. HOWEVER, IT IS POSSIBLE THAT THE METAL PLATE COULD HAVE CAUSED THIS TYPE OF INJURY WITH APPLIED PRESSURE. THERE IS NO INDICATION OF ANY INJURY PRACTICES WERE FOLLOWED (BLOOD SAMPLES AND VACCINATIONS) AS A PRECAUTION. IN 2006, THE MANUFACTURER IMPLEMENTED A SYSTEM WITH RADIUS CORNERS AND EDGES. THE OLA2500 SYSTEM MENTIONED IN THIS EVENT WAS PRODUCED PRIOR TO THAT MODIFICATION. THE FOREIGN MANUFACTURER WILL INITIATE A FIELD MODIFICATION TO BE IMPLEMENTED IN THE USA BY OLYMPUS AMERICA INC. FIELD SERVICE ENGINEERS. THE MODIFICATION WILL PROVIDE A PROTECTIVE COATING TO BE APPLIED TO POTENTIALLY SHARP EDGES. NO INCIDENT OF THIS TYPE HAS OCCURRED IN THE USA, THAT OLYMPUS AMERICA INC. IS AWARE OF.

Description of Event or Problem · 1

COMPLAINT WAS RECEIVED FROM OUTSIDE THE USA. DURING ROUTINE CLEANING OF THE SYSTEM, THE LABORATORY TECHNICIAN REPORTEDLY CUT THIS THUMB ON A METAL PLATE THAT IS EXPOSED TO BIOLOGICAL FLUIDS. NO INFORMATION HAS BEEN RECEIVED TO SUGGEST ANY ILL EFFECTS ASSOCIATED WITH THE CUT. ACCORDINGLY, THIS EVENT IS BEING FILED IN A EXCESS OF CAUTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OLYMPUS LAB AUTOMATION SYSTEM	CALCULATOR/DATA PROCESSING MODULE FOR	JQP	OLYMPUS DIAGNOSTICA LAB AUTOMATION GMBH	OLA2500	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA YR		Required Intervention