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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE POWER SUPPLY FOR 26 VISION ELECT HDTV; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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STRYKER ENDOSCOPY-SAN JOSE POWER SUPPLY FOR 26 VISION ELECT HDTV; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 0240030950
Device Problems Smoking (1585); Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 11/17/2015
Event Type  malfunction  
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.
 
Event Description
It was reported that during set up for the surgery, spark and smoke came out of the transformer when the monitor was switched on for testing.The device was turned off immediately and quarantined.Another device was on hand for the procedure.There was no patient involvement and no adverse consequences.
 
Manufacturer Narrative
The reported device was not received for investigation; therefore the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: display design.Power supply material.Isolation power failure.Fuses fail to break circuit due to excessive mains current leading to fire.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.
 
Event Description
It was reported that during set up for the surgery, spark and smoke came out of the transformer when the monitor was switched on for testing.The device was turned off immediately and quarantined.Another device was on hand for the procedure.There was no patient involvement and no adverse consequences.
 
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Brand Name
POWER SUPPLY FOR 26 VISION ELECT HDTV
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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 Key5304902
MDR Text Key34326932
Report Number0002936485-2015-01123
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0240030950
Device Lot Number80200515
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2015
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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