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

Catalog Number	0408801500
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Discarded at account.
Event or Problem Description
It was reported that during a procedure at the user facility, blood and fluids were saturating and penetrating the hood.No blood or fluids came into contact with the surgeon's skin.The procedure was completed successfully.Attempts are being made to obtain additional information from the user facility.
Event or Problem Description
It was reported that during a procedure at the user facility, blood and fluids were saturating and penetrating the hood.No blood or fluids came into contact with the surgeon's skin.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.

• Brand Name: FLYTE SURGICOOL HOOD, PEELAWAY
• Common Device Name: HOOD, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9182627
• Report Number: 0001811755-2019-03220
• Device Sequence Number: 19480863
• Product Code: FXY
• UDI-Device Identifier: 37613252661086
• UDI-Public: 37613252661086
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K140588
• 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): 02/04/2020

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: 0408801500
• Device Lot Number: 18092535
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1