FDA Adverse Event
Malfunction
Summary report: N
M530 OHX
MDR report key: 20154806
·
Received September 6, 2024
Report
- Report Number
- 3003974370-2024-00008
- Event Type
- Malfunction
- Date Received
- September 6, 2024
- Date of Event
- August 26, 2024
- Report Date
- March 20, 2025
- Manufacturer
- LEICA MICROSYSTEMS (SCHWEIZ) AG
- Product Code
- EPT
- UDI-DI
- 07630003577112
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW-UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING INVESTIGATION.
Additional Manufacturer Narrative · 0
UDI / GUDID RELATED DATA QUALITY UPDATES ONLY.
Additional Manufacturer Narrative · 0
THIS IS A FINAL REPORT. AN INVESTIGATION OF THE AFFECTED DEVICE REVEALED THAT THE MALFUNCTION WAS DUE TO A BURNT NTC (R15) ON THE POWER DISTRIBUTION BOARD OF A 4-YEAR-OLD UNIT. IT WAS CONCLUDED THAT THE DEFECT IS A RANDOM COMPONENT FAILURE. REPLACING THE POWER DISTRIBUTION BOARD RESOLVED THE ISSUE AND THE UNIT WORKED ACCORDING TO SPECIFICATIONS.
Description of Event or Problem · 0
LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM JAPAN STATING THAT AN M530 OHX HAD A LOSS OF ILLUMINATION DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1864603 | M530 OHX | SURGICAL MICROSCOPE | EPT | LEICA MICROSYSTEMS (SCHWEIZ) AG | 10448704 | 07630003577112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |