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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1488 HD 3 CHIP CAMERA CONTROL UNIT (CCU); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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STRYKER ENDOSCOPY-SAN JOSE PKG, 1488 HD 3 CHIP CAMERA CONTROL UNIT (CCU); LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 1488010000
Device Problems Connection Problem (2900); Output Problem (3005)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2023
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.
 
Event Description
It was reported that there was loss of image.
 
Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: flickering.Probable root cause: cables, connectors, digital board, power supply, filter / fuse, ac inlet board , main board, transition board, fiber board, intermittence between transition board and ch connector, software, scope (see rsk10356 output "visualization/image"), light source (see rsk10975 output "white light"), camera head (sensor, sensor cable), coupler (dust on optics, scratched optics, broken / shifted lenses, focusing mechanism, endoclamp, zoom ring), 1488 & 1588 extension cable, intermittence while using rf devices (ex: valleylab), problem toggling light source or from camera head, connected monitors, leaking, use error, poor grounding (e.G."finger" grounding tab connecting front and rear enclosure.Camera head connection from cable to transition board.) electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge, and manufacturing/ service nonconformity.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
 
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Brand Name
PKG, 1488 HD 3 CHIP 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 Key16420492
MDR Text Key310075587
Report Number0002936485-2023-00137
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier07613327061024
UDI-Public07613327061024
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 Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/09/2023
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 Model Number1488010000
Device Catalogue Number1488010000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/24/2023
Initial Date FDA Received02/22/2023
Supplement Dates Manufacturer Received01/24/2023
Supplement Dates FDA Received05/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2014
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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