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

Model Number 1688010000

Device Problem Poor Quality Image (1408)

Patient Problems Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/31/2021

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 conversion to open procedure.

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: image flipped.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 from rf communication, hf surgical instruments, esd, or power surge; cybersecurity attack; pendulum ch inertial measurement unit ; incident light from surgical scene is reflected by coupler/ch window; use error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.

Event Description

It was reported that there was conversion to open procedure.

• 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: hannah stalnaker ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12858207
• MDR Text Key: 281132392
• Report Number: 0002936485-2021-00673
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327420081
• UDI-Public: 07613327420081
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1688010000
• Device Catalogue Number: 1688010000I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other