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 09/30/2020

Event Type  malfunction  

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 for 45 seconds, during the procedure.Please note that the procedure was completed successfully with no reports of adverse consequences.

Event Description

It was reported that there was image loss for 45 seconds, during the procedure.Please note that the procedure was completed successfully with no reports of adverse consequences.

Manufacturer Narrative

Alleged failure: setup: 1688 ccu port 1 -> hub -> tx -> primary display on cart tx -> rx -> secondary display.This specific tx worked fine for a day of cases.Then was showing flashing red after about 10 minutes of linking and dropped link.This tx was used in a procedure for synk 4k limited launch.About 10 min into the procedure, showed flickers (for less than 5 seconds) every few minutes on both primary and secondary display.Eventually video was completely lost on both displays.The on site specialist re-wired the tower in less than a minute to bypass tx.The video was lost for approximately 45 seconds.Tx: (b)(6).Rx: (b)(6).Hub version: 1.2.2.385.Display version: 1.2.2.385.Video source: 1688.Conclusion: root cause of issue is due to a faulty fan component p43585.As discussions with fan component manufacturer sunon indicated that fan shelf life may be a factor that was not considered in the component design specifications, further investigation and containment will be documented as part of nc (b)(4).The product was returned for investigation and the failure(s) identified is consistent with the complaint record.Failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• 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
• MDR Report Key: 10743919
• MDR Text Key: 214636386
• Report Number: 0002936485-2020-00431
• Device Sequence Number: 1
• Product Code: OUG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1