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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1688 CAMERA CONTROL UNIT (CCU); LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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STRYKER ENDOSCOPY-SAN JOSE PKG, 1688 CAMERA CONTROL UNIT (CCU); LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 1688010000
Device Problems No Display/Image (1183); Loss of Power (1475)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2021
Event Type  malfunction  
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 there was loss of image.
 
Manufacturer Narrative
Alleged failure: power cycled itself in the middle of a case.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Root cause: probable root causes could be attributed to a power surge, the cart, a loose connection or a faulty power cable.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
 
Event Description
It was reported that there was loss of image.
 
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Brand Name
PKG, 1688 CAMERA CONTROL UNIT (CCU)
Type of Device
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key11621637
MDR Text Key245424431
Report Number0002936485-2021-00197
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier07613327420081
UDI-Public07613327420081
Combination Product (y/n)N
PMA/PMN Number
K182160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1688010000
Device Catalogue Number1688010000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2021
Date Manufacturer Received03/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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