MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T5 HOOD W/ PEELAWAY; GOWN, SURGICAL

Catalog Number	0400800100
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure at the user facility, a white foreign material dropped off the hood.The procedure was completed successfully without a clinically significant delay, adverse consequences, or medical intervention.

• Brand Name: T5 HOOD W/ PEELAWAY
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7925637
• Report Number: 0001811755-2018-01700
• Device Sequence Number: 19409533
• Product Code: FYA
• UDI-Device Identifier: 34546540502651
• UDI-Public: 34546540502651
• Combination Product (Y/N): N
• PMA/510(K) Number: K063005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2018

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: 0400800100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1