MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS FLAT PANEL SPRING ARM, EDS SUSPENSION, 15-21KG

Catalog Number 0682400034

Device Problems Component Missing (2306); Component Misassembled (4004)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that in or 2, the yoke separated from the flat panel spring arm.A stryker field service technician (sfst) was dispatched for investigation.During his inspection, the sfst found that the m3 safety segment screw and the keeper clip, which are used to secure the flat panel yoke to the spring arm, were missing.The sfst then proceeded with the repairs by reinstalling the yoke onto the spring arm, installing a new keeper clip into the safety segment area.The safety segment cuff was re-installed and was secured with a new m3 safety segment screw.A functional test was performed to ensure the yoke was properly secured to the spring arm.The yoke and the spring arm were found to be working to specification, and the equipment was placed back into service.The sfst interviewed the hospital staff to determine how the m3 safety segment screw and keeper clip became missing.The staff was unaware on how the hardware had become missing and were not aware of any hospital staff performing maintenance on the equipment.The installation qip for the surgical light system was properly installed and passed final qc inspection on 29oct2013.The service history investigation revealed seven service reports associated with or2, of which all equipment functional testing was performed and the equipment was found to be working to specification.Since 09feb2018, neither the surgical lights or the flat panel monitor equipment in this or have been serviced by stryker personnel.Although the exact root cause of this issue is unknown, potential root causes include improper service and maintenance by hospital personnel.There was no injury or adverse event reported.This failure mode will continue to be monitored through stryker communications¿ ncmb meeting process.

Event Description

It was reported that in or 2, the yoke separated from the flat panel spring arm.

• Brand Name: FLAT PANEL SPRING ARM, EDS SUSPENSION, 15-21KG
• Type of Device: FLAT PANEL SPRING ARM
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 1410 lakeside parkway #100; flower mound TX 75028
• Manufacturer (Section G): STRYKER-COMMUNICATIONS; 1410 lakeside parkway #100; flower mound TX 75028
• Manufacturer Contact: kimberly lynch ; 1410 lakeside parkway #100; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 9780018
• MDR Text Key: 188573886
• Report Number: 0002031963-2020-00001
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0682400034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1