FDA Adverse Event Malfunction Summary report: N

M530 OHX

MDR report key: 12232720 · Received July 27, 2021

Report

Report Number: 3003974370-2021-00012
Event Type: Malfunction
Date Received: July 27, 2021
Date of Event: June 29, 2021
Report Date: September 3, 2021
Manufacturer: LEICA MICROSYSTEMS (SCHWEIZ) AG
Product Code: EPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THIS IS A FINAL REPORT. AN INVESTIGATION OF THE REPORTED INCIDENT WAS CONDUCTED AND REVEALED, THAT THE MALFUNCTION WAS DUE TO A BURNT NTC (R15) ON THE VOLTAGE SELECTOR BOARD. TESTS ON A REPRESENTATIVE M530 OHX, A DESIGN REVIEW OF THE ELECTRONIC CIRCUITS INCLUDING COMPONENT SPECIFICATIONS AND AN INVESTIGATION ON THE AFFECTED VOLTAGE SELECTOR BOARD WAS PERFORMED. THE TESTS AND INVESTIGATION REVEALED THAT THE DESIGN IS ADEQUATE AND THE NTC "R15" IS WORKING WITHIN ITS SPECIFIED LIMITS. IT WAS CONCLUDED THAT THE DEFECTIVE COMPONENT NTC "R15" IS AN ISOLATED, RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE AND NO INDICATIONS FOR AN ADVERSE TREND. REPLACING THE VOLTAGE SELECTOR BOARD CORRECTED THE ISSUE AND THE DEVICE WAS FUNCTIONING ACCORDING TO SPECIFICATIONS.

Additional Manufacturer Narrative · 1

AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW-UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING INVESTIGATION.

Description of Event or Problem · 1

LEICA MICROSYSTEMS (B)(6) AG RECEIVED A COMPLAINT FROM USA STATING THAT A COMPONENT ON THE M530 OHX VOLTAGE SELECTOR FUSE BOARD OVERHEATED. THE ISSUE OCCURRED DURING PREPARATION PRIOR TO SURGERY. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS PERFORMED WITH ANOTHER DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1132615	M530 OHX	SURGICAL MICROSCOPE	EPT	LEICA MICROSYSTEMS (SCHWEIZ) AG	M530 OHX

Patients

Seq	Age	Sex	Outcome	Treatment
1