MAUDE Adverse Event Report: STERIS CORPORATION STERIS; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 5085

Device Problems Device Inoperable (1663); Unintended Movement (3026)

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

Event Date 02/03/2017

Event Type  malfunction  

Event Description

The patient was scheduled for laparoscopic robotic hysterectomy, bilateral salpingectomy, and possible supracervical.Because of her size, i used bean bag with gel under her and both her arms on her side on the arm board with the yellow foam, and put both her legs in black stirrups and make sure it is stable.Everything is okay, the dr.Checked the patient's position.We started the procedure, one trocar was in, and the dr.Wants the trendelenburg to visualize the uterus.The crna was the one managing the table but the table won't go to the trendelenburg.We reboot the table and see if it's working.It is working up and down, slide toward the feet and head so crna press the reverse trendelendurg to see if it's working.It works but when he's gonna press the trendelenburg it's not working again.I called for help just to see what's going on the table, a staff member came and checked the table.Meanwhile the resident told me that the patient's left leg is tilted.She was draped so i can't see what she's talking about so i crawled down the drape and try to hold her leg at the same time called the desk to send more hands because the patient was starting to slide down.Bunch of help came to me trying to stop the patient from falling.The patient slowly fell into the floor.Each body part has the support from us so she did not hit her back, head arms legs into something.We even put blanket on her back, shoulder and head to make sure it is supported even though she's on the floor.We rolled her and put the hover matt under her and lift her up to the stretcher and transferred to pacu.The patient is stable and conscious but still drowsy.

• Brand Name: STERIS
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• MDR Report Key: 6452967
• MDR Text Key: 71518264
• Report Number: 6452967
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: 5085
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR