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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. LITHO 100; SURGICAL LASER
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QUANTA SYSTEM S.P.A. LITHO 100; SURGICAL LASER Back to Search Results
Model Number PVMS00055
Device Problems Temperature Problem (3022); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2020
Event Type  malfunction  
Manufacturer Narrative
The problem may could be a component failure.We are unaware about operator injury.We are waiting for more information by the distributors.
 
Event Description
The laser system had a failure that did not allow to use it properly.No adverse effects to patient were reported.
 
Manufacturer Narrative
The problem could be traced to a component failure.We are unaware about operator/patient injury.
 
Event Description
The laser system had a failure that did not allow to use it properly.No adverse effects to patient were reported.
 
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Brand Name
LITHO 100
Type of Device
SURGICAL LASER
Manufacturer (Section D)
QUANTA SYSTEM S.P.A.
via acquedotto, 109
samarate, 21017
IT  21017
MDR Report Key10147317
MDR Text Key195243412
Report Number3004378299-2020-00081
Device Sequence Number1
Product Code GEX
UDI-Device Identifier08033945938369
UDI-Public08033945938369
Combination Product (y/n)N
PMA/PMN Number
K192600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 03/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberPVMS00055
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/16/2020
Initial Date FDA Received06/12/2020
Supplement Dates Manufacturer Received05/16/2020
Supplement Dates FDA Received03/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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