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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE VIDEO PROCESSOR/ILLUMINATOR (VPI); LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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STRYKER ENDOSCOPY-SAN JOSE VIDEO PROCESSOR/ILLUMINATOR (VPI); LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number PC9000
Device Problems Failure to Power Up (1476); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/04/2022
Event Type  malfunction  
Event Description
It was reported that the device lost image and powered off during a procedure.The users were unable to get the device to power back on, which resulted in a 15 minute delay while a replacement was brought in.The procedure was completed successfully and there was no report of adverse consequences.
 
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
 
Event Description
It was reported that the device lost image and powered off during a procedure.The users were unable to get the device to power back on, which resulted in a 15 minute delay while a replacement was brought in.The procedure was completed successfully and there was no report of adverse consequences.
 
Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: can not bootup probable root cause: electrostatic discharge.Cooling system (vpi) failure.Software error/failure.Camera overheating.Camera malfunction.Dropped camera.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
 
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Brand Name
VIDEO PROCESSOR/ILLUMINATOR (VPI)
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
burnaby
san jose CA 95138
Manufacturer (Section G)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
burnaby
san jose CA 95138
Manufacturer Contact
chester rebugio
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key15252529
MDR Text Key305275463
Report Number3012345110-2022-00004
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier00858701006049
UDI-Public00858701006049
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K150956
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician Assistant
Type of Report Initial,Followup
Report Date 10/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPC9000
Device Catalogue NumberPC9001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/11/2022
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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