MAUDE Adverse Event Report: STERIS CORPORATION STERIS HARMONY CONNECT POINT ARM; LIGHT SURGICAL, CEILING MOUNTED

Model Number STERIS HARMONY CONNECT POINT ARM

Device Problems Break (1069); Corroded (1131); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2019

Event Type  malfunction  

Event Description

Connect point video docking arm, the screws in the knuckle joint were falling out.The arm came out in the hand of the user.The threads that secure the screws are corroding allowing the screws to loosen and fall out.There was a previous report falling out and landing on the surgical field.In present case, screw fell out prior to surgery-no harm patient.Biomedical engineering staff inspected the joint in all operating rooms and found similar conditions; screws loose or missing.Do you have a picture of the product? yes.Fda safety report id # (b)(4).

• Brand Name: STERIS HARMONY CONNECT POINT ARM
• Type of Device: LIGHT SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): STERIS CORPORATION
• MDR Report Key: 8515387
• MDR Text Key: 142217738
• Report Number: MW5085873
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STERIS HARMONY CONNECT POINT ARM
• Device Catalogue Number: 1930560D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1