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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 Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2023
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.
 
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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
Manufacturer (Section G)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer Contact
benjamin ly
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key16961403
MDR Text Key315551741
Report Number0002936485-2023-00482
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
Reporter Occupation Other
Type of Report Initial
Report Date 05/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2023
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 Manufacturer05/05/2023
Date Manufacturer Received04/28/2023
Was Device Evaluated by Manufacturer? No
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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