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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY ARTHROSCOPE

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STRYKER ENDOSCOPY ARTHROSCOPE Back to Search Results
Model Number 747-031-560
Device Problems Break (1069); Component Falling (1105)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/22/2016
Event Type  malfunction  
Event Description
During arthroscopic knee surgery the arthroscopic cannula valve broke. All pieces were retrieved and sequestered. Event reached patient but caused no harm and no intervention or monitoring was required.
 
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Brand NameNA
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
STRYKER ENDOSCOPY
5900 optical court
san jose CA 95138
MDR Report Key6212779
MDR Text Key63534376
Report Number6212779
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number747-031-560
Device Catalogue Number747-031-560
Device Lot Number08D61151
Other Device ID Number5.8MM CANNULA, 2 FIXED STOPCO
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/28/2016
Event Location Hospital
Date Report to Manufacturer12/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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