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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. FAN SPRAY KIT; LAVAGE, JET

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ZIMMER SURGICAL, INC. FAN SPRAY KIT; LAVAGE, JET Back to Search Results
Model Number N/A
Device Problems Smoking (1585); Improper or Incorrect Procedure or Method (2017)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to the manufacturer at the time of this report.A follow up medwatch will be submitted once the device has been returned and the investigation is complete.
 
Event Description
It was reported that after the wires on the battery pack were cut, the pack was thrown on the back table of the operating room and some smoke came from the device.The amount of smoke is unknown.
 
Event Description
Additional information received on (b)(6) 2016 stated that the event occurred at the end of surgery after the pulsavac had been used; the device was thrown on backtable with no contact with patient or staff.There was no need to use another product as it was at the end of the case.
 
Manufacturer Narrative
(b)(4).This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Review of the device history record for 00515047501, lot number 63452273, identified no deviations or anomalies.Product examination found that the battery pack had ruptured from a short circuit due to a cut wire.This complaint is confirmed.The reported event claimed that the battery wire of the unit was cut and later on the battery pack became hot and close to combustion.It is known that cutting the wire can create a short circuit within the battery pack.The pulsavac ifu states, ¿do not cut the battery pack cable.Cutting through the battery pack cable could lead to shock, excessive heat and/or sparks, and could result in fire and/or personal injury.¿ the root cause for this complaint is that the customer cut the wire, creating a short circuit within the battery pack.This short circuit caused the reported event.
 
Event Description
Additional information was received: user facility mentioned that they cut the wires on the device.In addition, the facility stated the "writing on the label should be bigger or more defined so as this may not happen again.".
 
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Brand Name
FAN SPRAY KIT
Type of Device
LAVAGE, JET
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer (Section G)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key6199840
MDR Text Key63490155
Report Number0001526350-2016-00158
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 06/28/2017
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 Expiration Date08/31/2019
Device Model NumberN/A
Device Catalogue Number00515047501
Device Lot Number63452273
Other Device ID Number00889024375154
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/12/2016
Initial Date FDA Received12/22/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received01/03/2017
06/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
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