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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 4MM 30° C-MOUNT STYLE A ARTHROSCOPE

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STRYKER ENDOSCOPY-SAN JOSE 4MM 30° C-MOUNT STYLE A ARTHROSCOPE Back to Search Results
Catalog Number 0502427030
Device Problem Insufficient Information (3190)
Patient Problem Burn(s) (1757)
Event Date 07/07/2016
Event Type  Injury  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed. The device manufacture date is not known at this time. However, should it become available it will be provided in future reports. Gtin: (b)(4).
 
Event Description
It was alleged that the patient was burned. Further information confirmed that there was no surgical delay or medical intervention.
 
Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed. Alleged failure: patient burned. Probable root cause: too much light from light source. Light source left on and scope/adapter left on or in patient. Reflected laser energy to the scope when used with laser equipment. Electrical discharge or coupled hf current when used with hf surgical equipment. The failure mode will be monitored for future reoccurrence. Mfg date: manufacture date is not known since the serial / lot number was not provided and the device was not received. (b)(4).
 
Event Description
It was alleged that the patient was burned. Further information confirmed that there was no surgical delay or medical intervention.
 
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Brand Name4MM 30° C-MOUNT STYLE A ARTHROSCOPE
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer (Section G)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer Contact
kimberly lynch
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key5837923
MDR Text Key50904725
Report Number0002936485-2016-00708
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093677
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0502427030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2016
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 Treatment Data
Date Received: 08/01/2016 Patient Sequence Number: 1
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