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 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

The armboard was removed from service following the event.Photographs of the damaged armboard were reviewed by steris quality.The photographs reveal a splintered surface of the armboard subject of the event.Based on the description of the event and photographs provided; it appears the armboard had been damaged prior to use due to impact damage.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 account manager will offer in-service on the importance of inspecting the armboard prior to use.No additional issues have been reported.

Event Description

The user facility reported that two employees injured by the carbon fiber surface of an armboard while positioning the device onto the surgical table.No medical treatment was sought or administered.

Manufacturer Narrative

Dta personnel counseled the user facility on the importance of inspecting the armboard prior to use and 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: 7622711
• MDR Text Key: 112445557
• Report Number: 1043572-2018-00048
• 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,Followup
• Report Date: 06/20/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 05/21/2018; 05/21/2018
• Supplement Dates FDA Received: 07/27/2018; 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1