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

Catalog Number	0408731000
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Discarded by the customer.
Event or Problem Description
It was reported that during setup prior to a surgical procedure at the user facility, a tear was found on the toga.There was no patient involvement, no delay, no medical intervention and no adverse consequences with this event.

• 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: 8086506
• Report Number: 0001811755-2018-02515
• Device Sequence Number: 1721772
• Product Code: FYA
• UDI-Device Identifier: 37613327117074
• UDI-Public: 37613327117074
• Combination Product (Y/N): N
• PMA/510(K) Number: K141095
• 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): 11/19/2018

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: 0408731000
• Device Lot Number: 17123323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1