MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SURGISTOOL; STOOL, OPERATING-ROOM

Catalog Number 0830000000

Device Problem Device Tipped Over (2589)

Patient Problem Fall (1848)

Event Date 05/06/2014

Event Type  malfunction  

Event Description

It was reported that the customer had an incident of a personnel tipping over backwards off the surgistool when pushing away from patient.No parts on the stool was noted to have failed at this time.

Event Description

It was reported that the customer had an incident of a personnel tipping over backwards off the surgistool when pushing away from patient.No parts on the stool was noted to have failed at this time.

Manufacturer Narrative

The alleged condition of the stool tipping is likely user error.However, this could not be confirmed as the unit was not made available to stryker for evaluation.A likely cause to the event is due to the customer leaning too far back while pushing the stool backwards, causing a tip.The device was not made available for evaluation.

• Brand Name: SURGISTOOL
• Type of Device: STOOL, OPERATING-ROOM
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: lucas fischhaber ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3866057
• MDR Text Key: 4535240
• Report Number: 0001831750-2014-03059
• Device Sequence Number: 1
• Product Code: FZM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0830000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2014
• Was Device Evaluated by Manufacturer?: No
• 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