MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3080R SURGICAL TABLE

Device Problem Device Inoperable (1663)

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

Event Type  malfunction  

Manufacturer Narrative

A steris technician was dispatched to the user facility to inspect the surgical table upon receiving the medwatch report.The steris technician confirmed the facility's biomed technician did not attempt to repair the surgical table as stated in the medwatch report.The technician stated that the surgical table would not lock at its lowest position which could be attributed to a loose cable within the base of the surgical table.The technician found that contrary to the customer's medwatch report, the reported event is not due to inadequate labeling of the device but rather required table servicing activities.The technician also found that all labeling on the surgical table was present.The surgical table is approximately 28 years old and is not serviced or maintained by steris.The user facility is responsible for all maintenance activities.A review of service records indicates that steris has not performed any repairs on this table.All 3080 surgical tables are equipped with an operator manual and labelling on the table appropriate to its operating characteristics.The 3080r surgical table operator manual also states (pg.6-1), "warning - personal injury and/or equipment damage hazard: safe and reliable operation of this equipment requires regularly scheduled preventive maintenance, in addition to the regular routine maintenance.Contact steris to schedule preventive maintenance." a letter of obsolescence was issued in 2007 for the surgical table.Replacement components are no longer manufactured due to the obsolescence.Per discussion with the technician, user facility personnel were unaware a medwatch report was submitted as their previous supervisor was the one who submitted this report.Steris is awaiting a response from the user facility on how to precede with the surgical table specifically if repairs will be conducted, or if the user facility will purchase a new surgical table.

Event Description

The user facility reported via medwatch # (b)(4) that their 3080r surgical table would not lock.The reported event did not occur during a patient procedure.No report of injury, procedure delay or cancellation.

• Brand Name: 3080R 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: 7119095
• MDR Text Key: 95199353
• Report Number: 1043572-2017-00081
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2017
• 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