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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
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STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED Back to Search Results
Model Number CTS02
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 10/29/2014
Event Type  malfunction  
Event Description
It was reported that there is an unknown substance inside of the packaging.There was no patient involvement.There was no medical treatment or intervention and no adverse consequences associated with this event.
 
Manufacturer Narrative
An investigation has not yet been completed for this event.A supplemental will be submitted once the investigation is complete.
 
Manufacturer Narrative
The complaint device was returned to stryker sustainability solutions (sss) for an evaluation.The packaging was received sealed.Clear moisture/ precipitation was noted inside the sealed packaging.Laboratory testing conducted confirmed the presence of poly(dimethylsiloxane), also known as silicone.The most likely root cause is excessive lubricant on the device.The device history record (dhr) was reviewed to confirm the device met all inspection and testing requirements prior to distribution.Instructions for use (ifu) "careful handling of instruments is necessary to avoid damage or breakage." "inspect the instruments for any damage.Do not use the instrument if any damage is noted.Return the instrument and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery." the reported event will continue to be monitored through post-market surveillance.
 
Event Description
It was reported that there is an unknown substance inside of the packaging.There was no patient involvement.There was no medical treatment or intervention and no adverse consequences associated with this event.
 
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Brand Name
NA
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5307 great oak drive
lakeland FL 33815
Manufacturer (Section G)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5307 great oak drive
lakeland FL 33815
Manufacturer Contact
moira barton varty
1810 w. drake drive
tempe, AZ 85283
8888883433
MDR Report Key4282300
MDR Text Key5298118
Report Number0001056128-2014-00135
Device Sequence Number1
Product Code NLM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063788
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2016
Device Model NumberCTS02
Device Catalogue NumberCTS02RR
Device Lot Number3212965
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/11/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse
Patient Sequence Number1
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