MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE HELMET; HELMET, SURGICAL

Catalog Number 0408600000

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2016

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure there was smoke coming out of the front nozzle of the device.The procedure was completed successfully without a surgical delay, and no adverse consequences or medical intervention.

Manufacturer Narrative

The device was not returned for analysis.

Event Description

It was reported that during a surgical procedure, there was smoke coming out of the front nozzle of the device.The procedure was completed successfully without a surgical delay, and no adverse consequences or medical intervention.

• Brand Name: FLYTE HELMET
• Type of Device: HELMET, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5433574
• MDR Text Key: 38100111
• Report Number: 0001811755-2016-00191
• Device Sequence Number: 1
• Product Code: FXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0408600000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2014
• 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