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	Burn(s) (1757); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that an equipment booms electrical rotational brakes disengaged when a cauterizer device was used by a physician.This resulted in the equipment boom to drift horizontally and caused unintentional movement of the cauterizer wand, nicking the patient, and caused excessive bleeding.The excessive bleeding caused additional medical intervention but caused a 45-minute delay in surgery.A stryker field service technician (sfst) was dispatched to the account to perform the investigation.The sfst went on-site but was unable to re-create the issue.Although we couldn¿t confirm the root cause the issue is most likely due to the mfr captive board.The sfst installed a new mfr board and confirmed that the boom was operational.If any further information is obtained a supplemental will be filed.
Event or Problem Description
It was reported in operating room 7 boom floating caused patient injury while cautery was in-use during a case.
Additional Manufacturer Narrative
It was further reported that while the surgeon was performing ¿a loop electrocautery excision procedure.The boom migrated significantly, causing the loop the surgeon was using to slice across the patient's cervix.This resulted in a laceration that needed surgical repair and extension of the surgical time.¿ an extension of time was previously mentioned.Additionally, the results code grid was updated to "conducted interference" to more accurately describe the results that occurred.
Event or Problem Description
It was reported in or 7 boom floating caused patient injury while cautery was in-use during a case.

• 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: 10579926
• Report Number: 0002031963-2020-00002
• Device Sequence Number: 436477
• Product Code: FQO
• UDI-Device Identifier: 07613327400502
• UDI-Public: 07613327400502
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 09/02/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention