MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY ARMBOARD WITH GRAVITY LATCH; ARMBOARD TO SURGICAL TABLE

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

Patient Problem Injury (2348)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

The armboard was removed from service following the reported event and is being returned to steris for evaluation.A follow-up mdr will be submitted when additional information become available.

Event Description

The user facility reported that an employee obtained a cut from the surface of their armboard.It is unknown if medical treatment was sought or administered.

Manufacturer Narrative

Following the reported event, a steris service technician spoke with facility personnel who stated that contrary to the reported event, the employee did not obtain a cut.No injury occurred and no medical treatment was sought or administered.The technician arrived onsite inspect the 3085 surgical table that was utilized with the armboard subject of the event; however, facility personnel could not confirm which of their ten 3085 surgical tables was utilized at the time of the reported event.The technician inspected the side rails of all ten surgical tables where the armboard connects to the table and the tables were found to be operating properly.No repairs were required.The armboard subject of the event was evaluated by steris engineering and found to be operating properly.No sharp edges were identified.The customer was provided a replacement armboard.No additional issues have been reported.

• Brand Name: ARMBOARD WITH GRAVITY LATCH
• Type of Device: ARMBOARD TO SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• MDR Report Key: 9299571
• MDR Text Key: 197595178
• Report Number: 1043572-2019-00096
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

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
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1