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 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the armboard and found there to be damage to the unit.The technician determined the armboard had been damaged prior to the reported event.The armboard instructions for use states, "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 service technician counseled user facility personnel on the importance of inspecting the armboard prior to use as well as proper handling practices to avoid damage to the armboard.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained a splinter in their finger from the surface of an armboard.The employee removed the splinter and continued working.No medical treatment was sought.

• 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
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, oh ; 3927453
• MDR Report Key: 9879455
• MDR Text Key: 209013257
• Report Number: 1043572-2020-00017
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• 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
• Date Manufacturer Received: 02/24/2020
• 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