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

Catalog Number 0408645000

Device Problem Overheating of Device (1437)

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

Event Date 01/17/2014

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure at the user facility the device overheated.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.

Event Description

It was reported that during a surgical procedure at the user facility, the device overheated.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The reported melting was not able to be confirmed by a manufacturer repair technician through visual inspection since the component that allegedly melted was missing when the device was received.Upon disassembly for visual examination, no components were identified which would have likely caused or contributed to the reported failure.Since this product is not a repairable item, it was disposed of by the manufacturer facility and not returned to the user facility.

• Brand Name: FLYTE LIGHTED HELMET BP
• 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: 3623888
• MDR Text Key: 4177666
• Report Number: 0001811755-2014-00444
• 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: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0408645000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2012
• 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