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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE AUTOCLAVABLE HAND CONTROL ARTHROSCOPE

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STRYKER ENDOSCOPY-SAN JOSE AUTOCLAVABLE HAND CONTROL ARTHROSCOPE Back to Search Results
Catalog Number 0350220000
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 09/08/2016
Event Type  malfunction  
Manufacturer Narrative
The device manufacture date is not known at this time. However, should it become available it will be provided in future reports. Additional information will be provided once the investigation has been completed. (b)(4).
 
Event Description
It was reported that the pump remote control shoots at the highest pressure automatically. There was no patient involvement and therefore no adverse consequence.
 
Manufacturer Narrative
Alleged failure: automatic button function. The failure(s) identified in the investigation is consistent with the complaint record. Probable root causes could be normal wear and tear, exceeded, unwanted movement of internal wiring. The product was returned for investigation and the failure mode will be monitored for future reoccurrence. The device manufacturer date is not known. (b)(4).
 
Event Description
It was reported that the pump remote control shoots at the highest pressure automatically. There was no patient involvement and therefore no adverse consequence.
 
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Brand NameAUTOCLAVABLE HAND CONTROL
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 Key5996106
MDR Text Key56801017
Report Number0002936485-2016-00929
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963304
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 02/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0350220000
Device Lot Number1317691
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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