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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, MEDICAL POWER SUPPLY; CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO
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STRYKER ENDOSCOPY-SAN JOSE PKG, MEDICAL POWER SUPPLY; CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO Back to Search Results
Catalog Number 0240031004
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2016
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.
 
Event Description
It was reported the monitor stopped working during laparoscope procedure and that he power supply was no longer supplying power to the monitor.The customer expressed concern and there were no adverse consequences to the patient.
 
Manufacturer Narrative
(b)(4).The product was returned and the failure mode was confirmed.Visual inspection: no visible damage to the connector pins, wires and power brick.Functional inspection : the pkg, medical power supply was tested with a known working vision pro monitor and power chord.There was no power coming out of the pkg, medical power supply.Probable root cause/s could be a bad power supply due to a bad component inside the power brick.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
 
Event Description
It was reported the monitor stopped working during laparoscope procedure and that he power supply was no longer supplying power to the monitor.The customer expressed concern and there were no adverse consequences to the patient.
 
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Brand Name
PKG, MEDICAL POWER SUPPLY
Type of Device
CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO
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 Key5496140
MDR Text Key40388640
Report Number0002936485-2016-00256
Device Sequence Number1
Product Code FWB
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0240031004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2016
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
Patient Sequence Number1
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