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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported or 9 boom won't stop and is moving on its own side to side when cautery in-use.There were no reported injuries or adverse consequences.The stryker field service technician (sfst) has not been able to perform an onsite investigation but device evaluation is anticipated.Once the sfst has performed the investigation, a supplemental will be filed.
Event or Problem Description
It was reported or 9 boom won't stop and is moving on its own side to side when cautery in-use.There were no reported injuries or adverse consequences.
Event or Problem Description
It was reported or 9 boom won't stop and is moving on its own side to side when cautery in-use.There were no reported injuries or adverse consequences.
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.The equipment boom was manufactured before 22apr2020 and has the older style mfr board.Once our sfst was on-site he was able to confirm that the equipment boom had the older style mfr capacitive 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.Once parts were available, our sfst installed our current released mfr board and confirmed that the boom was operational.If any further information is obtained around this event, a supplemental will be filed.

• 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: 11334617
• Report Number: 0002031963-2021-00004
• Device Sequence Number: 3774338
• Product Code: FQO
• UDI-Device Identifier: 07613327400502
• UDI-Public: 07613327400502
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/01/2021

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: 01/18/2021
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/01/2021
• 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