MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, SYNK 4K WIRELESS TRANSMITTER; MEDICAL DEVICE DATA SYSTEM

Catalog Number 0240031065

Device Problems No Display/Image (1183); Connection Problem (2900)

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

Event Date 01/27/2023

Event Type  malfunction  

Event Description

It was reported that there was image loss during procedure.

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported that there was image loss during 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: transmitter lost connection probable root cause: ¿ tx antenna/main board ¿ rx antenna/main board ¿ connectors ¿ tx/rx software ¿ wireless channel availability ¿ wireless interference with other systems in the room ¿ use error ¿ faulty hdmi cable ¿ faulty fan resulting in increased device temperature ¿ excessive channel restriction the reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG, SYNK 4K WIRELESS TRANSMITTER
• Type of Device: MEDICAL DEVICE DATA SYSTEM
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16432766
• MDR Text Key: 310138749
• Report Number: 0002936485-2023-00157
• Device Sequence Number: 1
• Product Code: OUG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0240031065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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