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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER COMMUNICATIONS INC. SWITCHPOINT INFINITY; ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY
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STRYKER COMMUNICATIONS INC. SWITCHPOINT INFINITY; ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY Back to Search Results
Model Number 0678001000
Device Problems Break (1069); Component Incompatible (1108)
Patient Problem No Information (3190)
Event Date 06/01/2016
Event Type  malfunction  
Event Description
Stryker is using a very poor quality dvi connector for their video integration system.This type of connector keeps breaking very often, almost weekly.They are using a dvi connector that is not intended to be used for the amount of mechanical work that it is used for.We have 13 operating rooms in our facility and we replace this connector almost weekly.They break because they cannot withstand the weight of the cables that are used and also the amount of times that the dvi connector needs to be used on the daily basis.Manufacturer response for video integration system, (per site reporter): they have replaced the connector multiple times, but haven't come up with a solution.
 
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Brand Name
SWITCHPOINT INFINITY
Type of Device
ENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY
Manufacturer (Section D)
STRYKER COMMUNICATIONS INC.
571 silveron blvd.
flower mound TX 75028
MDR Report Key6910415
MDR Text Key88053465
Report Number6910415
Device Sequence Number1
Product Code OCS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2017
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number0678001000
Device Catalogue Number0678-001-000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/29/2017
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer09/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
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