MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 1688 AIM 4K CAMERA HEAD, C-MOUNT - INTERNATIONAL KIT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 1688210105I

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  

Event Description

It was reported that there was loss of image.

Manufacturer Narrative

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

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: goes blank mid cases.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.

Event Description

It was reported that there was loss of image.

• Brand Name: 1688 AIM 4K CAMERA HEAD, C-MOUNT - 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: 17357931
• MDR Text Key: 319375420
• Report Number: 0002936485-2023-00707
• 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: 1688210105I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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