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

Model Number	0682400550
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 1410 lakeside parkway #100; flower mound TX 75028
• MDR Report Key: 11499061
• Report Number: 0002031963-2021-00010
• Device Sequence Number: 14170478
• Product Code: FQO
• UDI-Device Identifier: 07613327400502
• UDI-Public: 07613327400502
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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
• Operator of Device: No Information
• Device Model Number: 0682400550
• Device Catalogue Number: 0682400550
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 87331
• Patient Sequence Number: 1