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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM; LAVAGE, JET
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ZIMMER SURGICAL, INC. PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM; LAVAGE, JET Back to Search Results
Model Number 00-5150-482-00
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/07/2023
Event Type  malfunction  
Event Description
This was not an event that contacted or affected the patient.This is a disposable supply that is a handheld device that runs off of batteries to pull in and sprays out saline to irrigate a wound.It immediately did not work correctly when activated.The motor could be heard running and a very small amount of smoke was seen coming from the handle due to it not pulling saline through the device as designed.The surgeon immediately stopped the activation of the device and got a new device.It was not a situation of smoke created into the environment and the smoke was only visible due to the surgical lights.Again no harm or contact with the patient.
 
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Brand Name
PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM
Type of Device
LAVAGE, JET
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
dover OH 44622
MDR Report Key18064748
MDR Text Key327486227
Report NumberMW5147691
Device Sequence Number1
Product Code FQH
UDI-Device IdentifierH129005150482001
UDI-Public+H129005150482001/2528365655892J22A
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number00-5150-482-00
Device Lot Number65655892
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2023
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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