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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORP STERIS 5085 SRT SURGICAL TABLE; TABLE, OPERATING-ROOM

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STERIS CORP STERIS 5085 SRT SURGICAL TABLE; TABLE, OPERATING-ROOM Back to Search Results
Model Number 5085
Device Problem Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/05/2019
Event Type  malfunction  
Event Description
During a laparoscopic appendectomy the patient was tilted less than ten degrees to the left.As surgeon was finishing the procedure, staff heard a loud metal "snap/pop".Staff saw patient began to shift to his left as the physicians began to brace and hold the patient.Staff assisted and braced patient from sliding further.Patient unharmed, sterility maintained and patient placed on new bed.There was discussion about the loud noise heard prior to the patient falling and this noise was able to be recreated with adding some pressure to the sliding pads as it hit the bed frame.After investigation of how the patient could have started to slide off the bed frame from the operating room table, it was concluded most likely the table pad was not secured in the pegs initially, prior to the patient getting on the bed.If the pegs were engaged in the frame we could not recreate a way for the pads to slide off the frame.There are 4 pegs on each of the plates, 2 of which snap into an opening to receive them and 2 which we believe caused the patient to slide.
 
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Brand Name
STERIS 5085 SRT SURGICAL TABLE
Type of Device
TABLE, OPERATING-ROOM
Manufacturer (Section D)
STERIS CORP
2720 gunter park drive east
montgomery AL 36109
MDR Report Key9395142
MDR Text Key168654108
Report Number9395142
Device Sequence Number1
Product Code FQO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/21/2019
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 No Information
Device Model Number5085
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/21/2019
Event Location Hospital
Date Report to Manufacturer12/02/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age18615 DA
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