MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS S-SERIES; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 0682400550

Device Problem Electromagnetic Interference (1194)

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

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that an equipment boom electrical rotational brakes disengaged when a cauterizer device was being used during a procedure.There was patient involvement due to the issue occurring during a procedure but there was no impact to the patient and caused no surgical delay.They experienced the issue when the patient was closed up.There were no reported injuries or adverse consequences.A stryker field service technician (sfst) was dispatched to the account to perform an investigation.The sfst confirmed the failure with the customer but was unable to recreate the issue while on-site.The sfst observed that the equipment boom mfr assembly had the old-style revision of capacitive touch board although we couldn't confirm the root cause we suspect the issue is most likely due to the previous version of mfr capacitive board.The newer revision capacitive touch board was redesigned and released back in april 2020 to be less susceptible to emi from high frequency devices.The sfst was unable to install the newer mfr capacitive touch board due to parts being backordered, once parts are available we will install the redesigned capacitive touch board.If any further information around this event is obtained we will file a supplemental.

Event Description

It was reported the cautery was in use during a case and the boom brakes disengaged in or 6.There were no reported injuries or adverse consequences.

Manufacturer Narrative

It was reported that once parts were available, the stryker field service technician (sfst) installed our current released mfr board and confirmed that the boom was operational.

Event Description

It was reported the cautery was in use during a case and the boom brakes disengaged in or 6.There were no reported injuries or adverse consequences.

• Brand Name: S-SERIES
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 1410 lakeside parkway #100; flower mound TX 75028
• MDR Report Key: 11024320
• MDR Text Key: 227656330
• Report Number: 0002031963-2020-00010
• Device Sequence Number: 1
• Product Code: FQO
• UDI-Device Identifier: 07613327400502
• UDI-Public: 07613327400502
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0682400550
• Device Catalogue Number: 0682400550
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1