MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T5 LT WT FIBER OPT SURG HELMET; HELMET, SURGICAL

Catalog Number 0400635000

Device Problem Overheating of Device (1437)

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

Event Date 01/11/2014

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure at the user facility the device felt warm due to a frayed cord.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.It was confirmed that there were no exposed wires and there was no injury associated with the reported overheating.

Manufacturer Narrative

The device is available for evaluation but has not yet been received.Additional information will be submitted once the device is received and the quality investigation is completed.

Event Description

It was reported that during a surgical procedure at the user facility, the device felt warm due to a frayed cord.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.It was confirmed that there were no exposed wires and there was no injury associated with the reported overheating.

Manufacturer Narrative

The reported frayed cord was confirmed by a manufacturer repair technician through visual inspection.It was confirmed that the outer sheath of the cord was damaged and that fiberoptics were exposed, which can lead to heat generation.The helmet is not a repairable device and will therefore not be returned to the user facility.

• Brand Name: T5 LT WT FIBER OPT SURG 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: 3621950
• MDR Text Key: 4135705
• Report Number: 0001811755-2014-00430
• 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: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0400635000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2013
• 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