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

Catalog Number 0400800000

Device Problems Material Fragmentation (1261); Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/06/2014

Event Type  malfunction  

Event Description

It was reported that during set up prior to a surgical procedure at the user facility foreign material was found in the sterile packaging of the product.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

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

Event Description

It was reported that during set up prior to a surgical procedure at the user facility, foreign material was found in the sterile packaging of the product.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

Reported foreign material was actually a piece of the device.The reported foreign material was confirmed by a manufacturer repair technician through visual inspection.During evaluation, it was confirmed that the foreign material was actually a piece of velcro from the device.A manufacturing issue was determined to be a potential cause of the material in the packaging.The hood is 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: 3914282
• MDR Text Key: 4494600
• Report Number: 0001811755-2014-02402
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• 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: 14030510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1