FDA Adverse Event
Malfunction
Summary report: N
LEICA M525 F50
MDR report key: 3953509
·
Received June 12, 2014
Report
- Report Number
- 3003974370-2014-00006
- Event Type
- Malfunction
- Date Received
- June 12, 2014
- Date of Event
- May 22, 2014
- Report Date
- May 23, 2014
- Manufacturer
- LEICA MICROSYSTEMS SCHWEIZ AG, MAX SCHMIDHEINY
- Product Code
- EPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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 THE INVESTIGATION.
Description of Event or Problem · 1
ON (B)(6) 2014, LEICA MICROSYSTEMS RECEIVED A COMPLAINT STATING THAT AN (B)(6) YEAR OLD PATIENT HAD A FIRST TO SECOND DEGREE EAR BURN AT THE CONCLUSION OF AN ENT SURGERY USING LEICA M525 F50 SURGICAL MICROSCOPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347887 | LEICA M525 F50 | MICROSCOPE, SURGICAL | EPT | LEICA MICROSYSTEMS SCHWEIZ AG, MAX SCHMIDHEINY | M525 F50 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Other |