Device adverse event reports (MAUDE)

VALLEYLAB · ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Covidien · Self-Activation or Keying, Device Displays Incorrect Message +1

MalfunctionInitial submissionMDR 50941444
Manufacturer contact zip ext
-439
Manufacturer contact state
MN
Manufacturer link flag
Y
Manufacturer g1 city
BOULDER
Manufacturer contact address 1
8200 Coral Sea St NE
Manufacturer contact pcity
+1(800)6
Event type
Malfunction
Report number
1717344-2026-01330
Product problem flag
Y
Date received
20260930
PMA pmn number
K151649
Date of event
20260911
Reprocessed and reused flag
N
Manufacturer contact zip code
55112
Reporter occupation code
OTHER HEALTH CARE PROFESSIONAL
Manufacturer contact plocal
+1(800)646-4633
Noe summarized
1
Manufacturer contact l name
Bocchino
Manufacturer g1 postal code
80301-3299
Manufacturer g1 state
CO
Reporter country code
US
Date added
20260930
Manufacturer contact f name
Mike
Device date of manufacturer
20230816
Reporter state code
CA
Mfr report type
Thirty-Day
Manufacturer contact country
US
Date changed
20260930
Health professional
Y
Summary report flag
N
Manufacturer g1 zip code ext
-329
Date report
20260929
Manufacturer g1 country
US
Manufacturer contact city
Mounds View
MDR report key
50941444
Date manufacturer received
20260911
Report source code
Manufacturer report
Manufacturer g1 zip code
80301
Manufacturer g1 name
Covidien
Adverse event flag
N
Single use flag
N
Manufacturer g1 address 1
6044 Longbow Court
Manufacturer contact postal code
55112-4391
Type of report
Initial submission
Source type
Health Professional
Device
  1. Device sequence number
    319554
    Date received
    20260930
    Brand name
    VALLEYLAB
    Generic name
    ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
    Manufacturer d name
    Covidien
    Manufacturer d address 1
    6044 Longbow Court
    Manufacturer d city
    BOULDER
    Manufacturer d state
    CO
    Manufacturer d zip code
    80301
    Manufacturer d zip code ext
    -329
    Manufacturer d country
    US
    Manufacturer d postal code
    80301-3299
    Device operator
    HEALTH PROFESSIONAL
    Model number
    VLFT10GEN
    Catalog number
    VLFT10GEN
    Device availability
    No
    Device report product code
    GEI
    Combination product flag
    N
    UDI di
    10884521516328
    UDI public
    (01)10884521516328(11)230816
    Harmonized identifiers (openFDA)
    Device name
    Electrosurgical, Cutting & Coagulation & Accessories
    Medical specialty description
    General, Plastic Surgery
    Regulation number
    878.4400
    Device class
    2
Product problems
Self-Activation or Keying, Device Displays Incorrect Message, Intermittent Energy Output
Patient
  1. Patient sequence number
    1
    Date received
    20260930
    Patient sex
    Unknown
    Patient problems
    No Clinical Signs, Symptoms or Conditions
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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.