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

Catalog Number 0400800000

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2017

Event Type  malfunction  

Event Description

It was reported that prior to a surgical procedure at the user facility, foreign material was found in the sterile packaging of the product.There was no patient involvement, no delay, no medical intervention and no adverse consequences with this event.

Manufacturer Narrative

As the device was not received in the original, sterile packaging, a root cause cannot be determined.

Event Description

It was reported that prior to a surgical procedure at the user facility, foreign material was found in the sterile packaging of the product.There was no patient involvement, no delay, no medical intervention and no adverse consequences with this event.

• 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: 6338654
• MDR Text Key: 67655310
• Report Number: 0001811755-2017-00617
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• PMA/PMN Number: FYA
• 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: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 16010094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 02/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2016
• 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