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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL ZIMMER AIR DERMATOME II HANDPIECE
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ZIMMER SURGICAL ZIMMER AIR DERMATOME II HANDPIECE Back to Search Results
Catalog Number 00-8851-001-00
Device Problems Failure to Power Up (1476); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2014
Event Type  malfunction  
Event Description
It was reported that the zimmer air dermatome ii handpiece would stop suddenly when in use and wouldn't restart.When it was tested after operation it started to work and stopped intermittently, secondary testing in the office produced a result that showed the device worked properly.It was reported that the surgeon had to obtain an alternate device to complete the surgery.Add'l info determined that the issue occurred during surgery; however there was no pt harm or surgical delay reported.
 
Manufacturer Narrative
The device was no returned to the mfr for eval.A follow up medwatch will be submitted once the investigation is complete.
 
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Brand Name
ZIMMER AIR DERMATOME II HANDPIECE
Type of Device
ZIMMER AIR DERMATOME II HANDPIECE
Manufacturer (Section D)
ZIMMER SURGICAL
200 west ohio ave.
dover OH 44622
Manufacturer Contact
kathleen smith
200 west ohio ave.
dover, OH 44622
3303438801
MDR Report Key3915810
MDR Text Key4489069
Report Number1526350-2014-00377
Device Sequence Number1
Product Code GFD
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 05/13/2014
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 Catalogue Number00-8851-001-00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/13/2014
Initial Date FDA Received06/12/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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