MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE SURGICOOL TOGA, XL, PULLOVER; GOWN, SURGICAL

Catalog Number	0408731000
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing conducted at the manufacturer facility, the device was found to be ripped.There was no medical intervention and no adverse consequences with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: FLYTE SURGICOOL TOGA, XL, PULLOVER
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10098369
• Report Number: 0001811755-2020-01337
• Device Sequence Number: 3540500
• Product Code: FYA
• UDI-Device Identifier: 37613327117074
• UDI-Public: 37613327117074
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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): 05/28/2020

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: 0408731000
• Device Lot Number: 19030528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1