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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: T.W. POWER SUPPLY; UNIT, CAUTERY, THERMAL, AC-POWERED
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T.W. POWER SUPPLY; UNIT, CAUTERY, THERMAL, AC-POWERED Back to Search Results
Model Number T.W. POWER SUPPLY
Device Problem Failure to Deliver Energy (1211)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Trackwise id # (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
 
Event Description
The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply won't turn on.Case had not started so they switched out box with replacement.No patient involvement.
 
Event Description
The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply won't turn on.Case had not started so they switched out box with replacement.No patient involvement.
 
Manufacturer Narrative
Trackwise # (b)(4).A lot history search is not applicable because this is a reusable, oem device.Due to the age of the device, a c of c is not readily available on-site.
 
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Brand Name
T.W. POWER SUPPLY
Type of Device
UNIT, CAUTERY, THERMAL, AC-POWERED
MDR Report Key11515213
MDR Text Key240621927
Report Number2242352-2021-00198
Device Sequence Number1
Product Code HQO
UDI-Device Identifier00607567700826
UDI-Public00607567700826
Combination Product (y/n)N
PMA/PMN Number
K052274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/15/2021
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 Health Professional
Device Model NumberT.W. POWER SUPPLY
Device Catalogue NumberC-VH-3010
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/23/2021
Initial Date FDA Received03/18/2021
Supplement Dates Manufacturer Received04/06/2021
Supplement Dates FDA Received04/06/2021
Patient Sequence Number1
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