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

Catalog Number	0408800000
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure at the user facility, lint from the device fell onto the surgical table.No lint particles fell into the patient wound site.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
Additional Manufacturer Narrative
Product consumed by customer.
Event or Problem Description
It was reported that during a surgical procedure at the user facility, lint from the device fell onto the surgical table.No lint particles fell into the patient wound site.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.

• Brand Name: FLYTE HOOD
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7818467
• Report Number: 0001811755-2018-01615
• Device Sequence Number: 2336519
• Product Code: FYA
• UDI-Device Identifier: 34546540591716
• UDI-Public: 34546540591716
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K063005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0408800000
• Device Lot Number: 18030786
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1