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

Catalog Number 0830000000

Device Problem Unintended Movement (3026)

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

Event Date 08/11/2014

Event Type  malfunction  

Event Description

It was reported by service report that the stool drifts when weight is applied.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported by service report that the stool drifts when weight is applied.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

The unit could not be located by the user facility for the service technician to evaluate and repair.

• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 4098206
• MDR Text Key: 4840815
• Report Number: 0001831750-2014-03260
• Device Sequence Number: 1
• Product Code: FZM
• 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
• Type of Report: Initial,Followup
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2014
• 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