MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY CONNECTPOINT; HARMONY CONNECTPOINT TO SURGICAL TABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the harmony connectpoint and spoke with facility personnel regarding the reported event.Facility personnel confirmed that following a patient procedure a nurse attempted to adjust the location of the connectpoint arm when she felt a "prick" from the top portion of the brake screw.The technician inspected the connectpoint arm and noticed a burr on the top portion of the brake screw which caused the reported event to occur.Upon further follow-up with facility personnel the technician learned that earlier that day the facility's maintenance team attempted to tighten the brake screw without first loosening the other three screws as instructed in the operator manual.The root cause of the burr can be attributed to facility personnel overtightening the brake screw.The technician replaced the friction brake assembly including all screws, tested the connectpoint, confirmed it to be operating according to specifications, and returned it to service.The technician counseled facility personnel on proper preventive maintenance activities for their harmony connectpoint, specifically how to adjust the brake screw.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained a metal splinter while operating their harmony connectpoint.Medical treatment was sought and administered.

• Brand Name: HARMONY CONNECTPOINT
• Type of Device: HARMONY CONNECTPOINT TO SURGICAL TABLE
• 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: 8823978
• MDR Text Key: 209026562
• Report Number: 1043572-2019-00063
• 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

• 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
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/24/2019
• 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