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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
Catalog Number 1688010000
Device Problems No Display/Image (1183); Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2024
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that there was dark image and 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 Key19130390
MDR Text Key340465922
Report Number0002936485-2024-00336
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier07613327420081
UDI-Public07613327420081
Combination Product (y/n)N
Reporter Country CodeUS
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 04/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1688010000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2024
Initial Date Manufacturer Received 04/08/2024
Initial Date FDA Received04/18/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2021
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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