MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1688 CAMERA CONTROL UNIT (CCU); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 1688010000

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2023

Event Type  malfunction  

Event Description

It was reported that there was loss of image.

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.

Manufacturer Narrative

The device was received at the local service facility for investigation.The technical service report indicates: e04 error message displayed, unit still under warranty.Probable root cause: cables, hdmi cables, connectors, digital board, power supply, filter / fuse, ac inlet board, main board, transition board, intermittence between transition board and ch connector, software, camera head, coupler, problem toggling light source, connected monitors, leaking, poor grounding, no/incorrect communication with light source, soaking cap disconnection during sterilization, electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge, pendulum ch inertial measurement unit (imu) and use error.Probable root cause: software, front board, digital board, lcd touch panel, device control, power supply, filter / fuse, connectors, degradation from cleaning (i.E.Uv disinfection), fluid ingress into lcd panel, authentication board failure, electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge, no/incorrect communication with light source, use error, the reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that there was loss of image.

• 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 Key: 16931001
• MDR Text Key: 315208392
• Report Number: 0002936485-2023-00457
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327420081
• UDI-Public: 07613327420081
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K182160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1688010000
• Device Catalogue Number: 1688010000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 55 YR