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 Type  malfunction  

Manufacturer Narrative

The armboard was removed from service following the reported event.A steris service technician arrived onsite following the reported event to inspect the armboard and found there to be a small crack on the bottom side of the armboard.Photographs of the damaged armboard were reviewed by steris engineering.The photographs reveal a stress fracture from excess weight being applied over time to that section of the armboard.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.If technical assistance or additional instructions are needed, call steris." at this time the customer has made no attempt to replace the armboard.A steris account manager offered in-service training on the proper use of the armboard however, the user facility declined.No additional issues have been reported.

Event Description

The user facility reported that an employee was injured by the carbon surface of an armboard while trying to remove the device 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: 8750249
• MDR Text Key: 150883937
• Report Number: 1043572-2019-00052
• 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: 07/01/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 07/01/2019
• 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