MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4085 SURGICAL TABLE

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the surgical table and found evidence of damage to the table's column covers.Per the technician's inspection, the column covers did not break into pieces as initially reported by facility personnel, but rather the two cover halves had partially separated and a portion of the column cover had become bent.To address the issue, the technician ordered new column covers.The facility's biomed department elected to repair the surgical table rather than steris performing the repair.The damage observed to the column covers is attributed to user facility personnel storing items on the base of the table.As facility personnel stored items on the base of the table and near/around the column covers, the items became caught on the column covers when articulating the table and subsequently the covers became bent over time.All items should be clear of the table base and column prior to a power-driven movement (up and down).The 4085 surgical table is manufactured with a warning label that is directly applied to the table base cover.This label contains a pictorial graphic indicating items should not be stored upon the table base.The label also includes the following text: "warning - do not store items on base - personal injury hazard/equipment damage hazard: failure to keep all personnel and equipment clear of the table before actuating any inertia-driven or power-driven movement could result in table damage and/or personal injury".The user facility does not have a service agreement with steris; the facility's biomed department is responsible for performing all service activities.Prior to receipt of the medwatch report, steris had not been contacted regarding any issues with this surgical table since (b)(6) 2017.A steris account manager offered in-service training on the proper use and operation of the surgical table, with focus on ensuring that items are not stored on the base of the table and the user facility has accepted this offer.The in-service training will be performed on may 2, 2019.

Event Description

The user facility reported via user facility medwatch report # (b)(4), that during a patient procedure their 4085 surgical table's column covers broke into pieces.The patient was stabilized by facility personnel and transferred to another table causing a procedure delay.The procedure was completed successfully.There were no injuries associated with the reported event.

• Brand Name: 4085 SURGICAL TABLE
• Type of Device: 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: 8529260
• MDR Text Key: 142754946
• Report Number: 1043572-2019-00027
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• 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: 03/19/2019
• 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