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

Catalog Number 1688010000I

Device Problems Electrical Power Problem (2925); Output Problem (3005)

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

Event Date 06/22/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that there was loss of image.

Event Description

It was reported that there was loss of image.

Manufacturer Narrative

The device was received at the local service facility for investigation.The technical service report indicates: pi#: (b)(6).Ro#:(b)(4).Account: (b)(6) hospital.Reported by the customer: faulty port connector.P/n #: (b)(6).S/n: (b)(6).Summary of evaluation: faulty transition board, picture is too bright when camera connected repair details: transition board replaced.Qip completed.All tests passed.Qip# 11314 rev.U.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 (sensor, sensor cable).¿ coupler (dust on optics, scratched optics, broken / shifted lenses, focusing mechanism, endoclamp, zoom ring).¿ problem toggling light source.¿ connected monitors.¿ leaking.¿ poor grounding (e.G camera head connection from cable to transition board.).¿ no/incorrect communication with light source.¿ soaking cap disconnection during sterilization.¿ electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge.¿ cybersecurity attack.¿ pendulum ch inertial measurement unit (imu).¿ use error.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: 1688 CAMERA CONTROL UNIT (CCU) - INTERNATIONAL KIT
• 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: 17357986
• MDR Text Key: 319375354
• Report Number: 0002936485-2023-00706
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K182160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1688010000I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1