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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS PACKAGE, VISUM LED 2 SURGICAL LIGHT, LC
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STRYKER-COMMUNICATIONS PACKAGE, VISUM LED 2 SURGICAL LIGHT, LC Back to Search Results
Catalog Number 0682400137
Device Problem Difficult To Position (1467)
Patient Problem No Patient Involvement (2645)
Event Date 10/10/2016
Event Type  Injury  
Manufacturer Narrative
It was reported that due to the stiffness of the operating lights, a nurse allegedly injured her neck trying to pull them down.The investigation on the device is anticipated, but not yet begun.When stryker can inspect the product, a supplemental will be filed to include the investigation results.There was no patient involvement as this occurred prior to the scheduled procedure.
 
Event Description
It was reported that due to the stiffness of the operating lights, a nurse allegedly injured her neck trying to pull them down.There was no patient involvement as this occurred prior to the scheduled procedure.
 
Manufacturer Narrative
It was reported that a nurse injured her neck trying to position an led light.The product was not returned to stryker.No product information or case details were provided after more than 3 contact attempts.The visum led 2 surgical lights operations and maintenance manual discusses how to correctly position the lights.The design guidance document, fs10061 revision yak, shows functional specifications that were used to verify the force required to position the light.The associated test reports show the system compliance to these specifications.It is believed that the root cause for the injury and the system being difficult to move is due to improper operation of the light system.Product not returned.
 
Event Description
It was reported that due to the stiffness of the operating lights, a nurse allegedly injured her neck trying to pull them down.There was no patient involvement as this occurred prior to the scheduled procedure.
 
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Brand Name
PACKAGE, VISUM LED 2 SURGICAL LIGHT, LC
Type of Device
SURGICAL LIGHT
Manufacturer (Section D)
STRYKER-COMMUNICATIONS
1410 lakeside parkway #100
flower mound TX 75028
Manufacturer (Section G)
STRYKER-COMMUNICATIONS
1410 lakeside parkway #100
flower mound TX 75028
Manufacturer Contact
jenny harris
1410 lakeside parkway #100
flower mound, TX 75028
9724107100
MDR Report Key6085270
MDR Text Key59354743
Report Number0002031963-2016-00016
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0682400137
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/10/2016
Initial Date FDA Received11/08/2016
Supplement Dates Manufacturer Received10/10/2016
Supplement Dates FDA Received12/20/2017
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 Reuse
Patient Sequence Number1
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