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

Catalog Number	0682400550
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	Hyperextension (4523)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by counsel that the patient sustained injuries in an incident which occurred on (b)(6) 2022, at (b)(6).After reviewing our service complaint history for (b)(6) there was a failure in which an equipment boom fell to the ground, but at the time it was reported that there was no patient or users injuries.We contacted a hospital contact recommended by our local sales representatives to gather more details and we learned that a user was injured while preparing the operating room for upcoming cases.The injury occurred as the user tried to prevent an equipment boom from falling, using her body to counteract its momentum, resulting in shoulder and back injuries.The user required imaging due to the injuries and took a six-month medical leave for strained muscles in the shoulder and upper back.It was determined that the equipment boom fell to the floor due to a structural issue, the correct hardware/bracket was not used reducing the strength of the connection.Without the proper hardware, the weight of the boom eventually caused the strut channel to deform around the bolt resulting in the lowered boom.Based on the information reported, the root cause was the hospital super structure which caused the stryker equipment boom to fall, there was no evidence of a malfunction of a stryker device.The 3rd party renovation company resolved the structural issue, and it was verified by a structural engineer that the structure was acceptable.A stryker field service technician (sfst) was dispatched to go on-site after the structure issue was resolved, the sfst was able to confirm that equipment was operational.If any further information is obtained around this event, a supplemental will be filed.
Event or Problem Description
It was reported that due to the boom falling, a nurse hurt her shoulder and back.She was then went on l&i for almost 6 months or more and still has some remnants pain on the shoulder and back.

• Brand Name: S-SERIES
• Common Device Name: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 571 silveron blvd; flower mound TX 75028
• Manufacturer (Section G): STRYKER-COMMUNICATIONS; 571 silveron blvd; flower mound TX 75028
• Manufacturer Contact: kimberly lynch ; 571 silveron blvd; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 18727457
• Report Number: 0002031963-2024-00001
• Device Sequence Number: 20284857
• Product Code: FQO
• UDI-Device Identifier: 07613327400502
• UDI-Public: 07613327400502
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2024

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: Other
• Device Catalogue Number: 0682400550
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown