MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 HOOD; GOWN, SURGICAL

Catalog Number 0400800000

Device Problem Material Fragmentation (1261)

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

Event Date 01/06/2014

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure at the user facility foreign material fibers fell off of the device.The procedure was completed successfully using back-up equipment.No delay, no medical intervention and no adverse consequences were reported with this event.

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.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, foreign material fibers fell off of the device.The procedure was completed successfully using back-up equipment.No delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The product in question was not returned; however, the reported foreign fibers that fell off the device were received for evaluation.It is not possible to determine the cause of the reported event without an evaluation of the device, but based on the piece of foreign material that was received, potential causes for the reported event include a manufacturing process problem, since it was determined that the material in question was an intermediary processing fabric used in the assembly process.The hoods are not a repairable device and will therefore not be returned to the user facility.

• Brand Name: T4 HOOD
• Type of Device: GOWN, 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: 3610540
• MDR Text Key: 4088978
• Report Number: 0001811755-2014-00369
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070078
• 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: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0400800000
• Device Lot Number: 13050733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1