MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HAND CONTROL TO 3085 SURGICAL TABLE; 3085 SURGICAL TABLE HAND CONTROL

Device Problems Device Inoperable (1663); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

No injuries occurred as a result of the reported event.The user facility personnel did not know to utilize the auxiliary override systems as discussed in the operator manual.The 3085 sp surgical table operator manual states (pp.5-1), "since there are several methods of control for the table, it is important to understand the hierarchy of the respective controls' override capability over other control methods".Per steris customer service representative, user facility personnel requested a replacement hand control.A replacement hand control has been delivered to the user facility.Multiple attempts have been made to contact the facility's or director however, steris has not received a response.User facility's biomed specialist made user facility personnel aware of the location and function of the auxiliary override systems.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure a 3085 surgical table's hand control became unresponsive.The procedure was cancelled as user facility personnel did not know the proper way to manually operate the surgical table.

• Brand Name: HAND CONTROL TO 3085 SURGICAL TABLE
• Type of Device: 3085 SURGICAL TABLE HAND CONTROL
• 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: lyndsey snyder ; 5960 heisley road; mentor, OH 44060 ; 4403927386
• MDR Report Key: 6708578
• MDR Text Key: 80024944
• Report Number: 1043572-2017-00048
• 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: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• 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: 06/12/2017
• 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