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

Model Number 0682400550

Device Problem Electromagnetic Interference (1194)

Patient Problems Burn(s) (1757); Hemorrhage/Bleeding (1888)

Event Date 09/02/2020

Event Type  Injury  

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 Description

It was reported in operating room 7 boom floating caused patient injury while cautery was in-use during a case.

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 Description

It was reported in or 7 boom floating caused patient injury while cautery was in-use during a case.

• 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: 10579926
• MDR Text Key: 208325711
• Report Number: 0002031963-2020-00002
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• 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: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention