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 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

The armboard was removed from service following the event.Based on the description of the event; it appears the armboard had been damaged prior to use.The armboard instructions for use state: warning: personal injury and/or equipment damage hazard- do not use equipment if worn, damaged or cannot be securely tightened.Cracked or splintered surfaces may cause injury.Inspect armboard prior to use.Damaged armboard must be replaced.Read and understand all instructions prior to use." in addition, every armboard has a warning label which states: warning-avoid patient or user injury.Check accessory for damage and wear prior to use.Do not use if any damage is apparent or device cannot be securely tightened.The steris account manager completed in-service training on 3/21/2018 with user facility personnel on the importance of inspecting the armboard prior to use.

Event Description

The user facility reported that an employee was injured on the carbon fiber surface of an armboard while reaching under the armboard to release it from the surgical table.No medical treatment was sought or administered.

• 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
• 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: 7363500
• MDR Text Key: 103413766
• Report Number: 1043572-2018-00026
• Device Sequence Number: 1
• Product Code: FQO
• 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: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/22/2018
• 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