MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY CALIFORNIA PACIFIC MC PACIFIC CAMPUS; SURGICAL TABLE

Device Problem Sticking (1597)

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

Event Date 06/16/2014

Event Type  No Answer Provided  

Event Description

The user facility reported their 5085 surgical table would not release from the locked position at the end of a patient procedure.The facility reset the hand control multiple times and physically pushed against the bed in order to unlock the table from the floor.A procedural delay was reported due to the issue described.

Manufacturer Narrative

A steris service technician arrived at the facility and was unable to duplicate the event as reported by the user facility; the table was locked and successfully unlocked several times using the 5085 table hand control.The technician inspected the surgical table and identified particles of dirt in the grooved rubber pads attached to the table's floor locking feet.The technician cleaned the pads, disassembled and reinstalled the table's foot cylinder assembly and confirmed the table was operating to specification.The table was installed in october of 2012 and is not under steris service contract.The steris 5085 operator manual (4-1) states, "in addition to routine maintenance, regularly scheduled preventive maintenance is essential for safe and reliable operation of the equipment." no further issues have been reported.

Manufacturer Narrative

Additional issues have been reported by the user facility pertaining to this table.The user facility was provided a replacement table, and the table subject of the reported event was sent back to steris for evaluation.The reported event could not be duplicated by steris engineering.No issues have been reported by the facility pertaining to the replacement table.

• Brand Name: CALIFORNIA PACIFIC MC PACIFIC CAMPUS
• 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 3944106
• MDR Text Key: 4536840
• Report Number: 1043572-2014-00061
• 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: 07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• 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: 06/20/2014
• 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