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

Catalog Number 0408600000

Device Problems Overheating of Device (1437); Smoking (1585); Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Event Description

The sales representative reported that the user facility experienced the device emitting sparks and smoke during a procedure.There were no reported adverse consequences; there was no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document device evaluation results.

Event Description

The sales representative reported that the user facility experienced the device emitting sparks and smoke during a procedure.There were no reported adverse consequences; there was no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.

• 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: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7512787
• MDR Text Key: 108233966
• Report Number: 0001811755-2018-00983
• 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: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0408600000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2018
• 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