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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG 1288HD CAMERA CONTROL UNIT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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STRYKER ENDOSCOPY-SAN JOSE PKG 1288HD CAMERA CONTROL UNIT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 1288010000
Device Problem Electrical Power Problem (2925)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2018
Event Type  malfunction  
Manufacturer Narrative
Alleged failure: producing smoke.The failure identified in the investigation is consistent with the complaint record.Root cause: ic u27 shorted out.This is an electrical component failure and it is difficult to predict the life time of electrical components.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
 
Event Description
It was reported that there was a thermal event.
 
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Brand Name
PKG 1288HD CAMERA CONTROL UNIT
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
michelle to
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key8203583
MDR Text Key131701163
Report Number0002936485-2018-00733
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier07613327063387
UDI-Public07613327063387
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132785
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number1288010000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2018
Date Manufacturer Received12/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2010
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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