MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY CONNECTPOINT; CONNECTPOINT TO HARMONY LED SURGICAL LIGHTING SYSTEM

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the harmony connectpoint.The technician found that the brakes on the swing arm had become loose over time, allowing the reported drift to occur.The technician tightened the brake and confirmed the connectpoint to be operating according to specification however, the technician removed the swing arm from the lighting system per the customer's request.The root cause of the reported event can be attributed to improper maintenance of the harmony connectpoint specifically, not regularly checking and tightening the brake on the harmony connectpoint.The harmony connectpoint is not under steris service agreement for maintenance activities.The facility's biomed department is responsible for all maintenance activities.The harmony connectpoint operator manual (pg 11-1) states: "the friction brakes may require adjustment over time.If the harmony connectpoint should drift when released during articulation, use the procedure to adjust brake tension and reduce drift." the harmony connectpoint preventive maintenance check list (pg.1) states: "verify suspension system does not drift.Adjust or replace knuckle brake kit as required 2 times per year." while onsite, the technician was able to counsel the facility's biomed department on the proper use and maintenance of the harmony connectpoint specifically, properly tightening the brake on the harmony connectpoint.No additional issues have been reported.

Event Description

The user facility reported their harmony connectpoint drifted at the beginning of a patient procedure making contact with the back of the patient's head.The procedure was completed successfully.No report of injury.

• Brand Name: HARMONY CONNECTPOINT
• Type of Device: CONNECTPOINT TO HARMONY LED SURGICAL LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8823943
• MDR Text Key: 209028594
• Report Number: 1043572-2019-00062
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2019
• 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