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	10/19/2020
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.A stryker field service technician (sfst) was dispatched to the account to perform an investigation but was unable to troubleshoot the product or gain access to the operating room.A few attempts were made to contact the customer to schedule a site visit.  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. if any further information is obtained around this event, a supplemental will be filed.
Event or Problem Description
It was reported ep lab 4 boom drifting when cautery is used during a procedure.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
It was reported that the stryker field service technician (sfst) was allowed access to the operating rooms.The sfst was able to confirm 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.The sfst installed our current released mfr board and confirmed that the boom was operational.The 'device evaluated by mfg' field was updated to 'yes.'.
Event or Problem Description
It was reported ep lab 4 boom drifting when cautery is used during a procedure.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: 10857245
• Report Number: 0002031963-2020-00008
• Device Sequence Number: 11002775
• Product Code: FQO
• UDI-Device Identifier: 07613327400502
• UDI-Public: 07613327400502
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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: 10/19/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1