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 02/17/2021

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.There were no reported injuries or adverse consequences.All of the equipment booms for this account were manufactured before 22apr2020 and have the older style mfr board.The sfst investigation results can be referenced on sales force complaint (b)(4), the case was closed because we are waiting to performing the pfa inspection.S-series capacitive touch emi disturbances has been investigated on nc/capa (b)(4).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.A stryker representative will be performing the pfa inspection and will install the current revision of mfr board and confirm that the boom is operational.Once additional information is obtained around this event, a supplemental will be filed.

Event Description

It was reported the brakes are clicking on the s-boom while cautery is in-use in or 11.There were no reported injuries or adverse consequences.

Manufacturer Narrative

Field d4 has been updated to include serial number.This boom is confirmed to be within scope of field action pfa2497567 (ref (b)(4)).A stryker representative will be performing the pfa inspection and will install the current revision of mfr board and confirm that the boom is operational.Field g6 has been updated to "follow-up report 001." field h9 has been updated to "additional information" and "correction.".

Event Description

It was reported the brakes are clicking on the s-boom while cautery is in-use in or 11.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: 11499061
• MDR Text Key: 243567181
• Report Number: 0002031963-2021-00010
• 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: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• 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
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 87331
• Patient Sequence Number: 1