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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG ARVEO 8; SURGICAL MICROSCOPE
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LEICA MICROSYSTEMS (SCHWEIZ) AG ARVEO 8; SURGICAL MICROSCOPE Back to Search Results
Model Number ARVEO 8
Device Problem Insufficient Information (3190)
Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)
Event Date 03/11/2024
Event Type  malfunction  
Event Description
Leica microsystems (schweiz) ag received a complaint from china related to an arveo 8 stating that a patient was discovered to have a 2nd degree burn after surgery was completed.
 
Manufacturer Narrative
An investigation of the incident is currently underway and a follow-up will be submitted should additional information become available following investigation.
 
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Brand Name
ARVEO 8
Type of Device
SURGICAL MICROSCOPE
Manufacturer (Section D)
LEICA MICROSYSTEMS (SCHWEIZ) AG
max-schmidheiny-strasse 201
heerbrugg, sankt gallen 9435
SZ  9435
Manufacturer (Section G)
LEICA INSTRUMENTS (SINGAPORE) PTE LTD
12 teban gardens crescent
singapore, 60892 4
SN   608924
Manufacturer Contact
manuel pfundstein
max-schmidheiny-strasse 201
heerbrugg, sankt gallen 9435
SZ   9435
MDR Report Key18949123
MDR Text Key339291401
Report Number3003974370-2024-00003
Device Sequence Number1
Product Code EPT
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberARVEO 8
Device Catalogue Number10449063
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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