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 No Code Available (3191)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

The user facility stated their armboard exhibited cracking and splintering of the carbon fiber material; the armboard is approximately seven years old.The armboard was removed from service following the event.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 advised user facility personnel the importance of inspecting the armboard prior to use.

Event Description

The user facility reported that an employee received a splinter while positioning the armboard.The employee sought and received medical treatment.

• 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: 7286410
• MDR Text Key: 100788333
• Report Number: 1043572-2018-00016
• 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,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2018
• 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