MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 ZIPPER TOGA, L/XL; GOWN, SURGICAL

Catalog Number	0400820000
Medical Device Problem Codes	Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection conducted at the user facility prior to the start of a surgical procedure, the outer coating on the front and sleeves of the gown appears to have come away from the backing material, as well as thinning and tearing of the outer layer.There was no patient involvement, no delay, no medical intervention, and no adverse consequences with this event.
Event or Problem Description
It was reported that during inspection conducted at the user facility prior to the start of a surgical procedure, the outer coating on the front and sleeves of the gown appears to have come away from the backing material, as well as thinning and tearing of the outer layer.There was no patient involvement, no delay, no medical intervention, and no adverse consequences with this event.
Additional Manufacturer Narrative
Device evaluation: device was not returned.
Event or Problem Description
It was reported that during inspection conducted at the user facility prior to the start of a surgical procedure, the outer coating on the front and sleeves of the gown appears to have come away from the backing material, as well as thinning and tearing of the outer layer.There was no patient involvement, no delay, no medical intervention, and no adverse consequences with this event.

• Brand Name: T4 ZIPPER TOGA, L/XL
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7556915
• Report Number: 0001811755-2018-01024
• Device Sequence Number: 14073932
• Product Code: FYA
• UDI-Device Identifier: 34546540152689
• UDI-Public: 34546540152689
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K070078
• 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,Followup
• Report Date (Section B): 12/11/2018

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: 0400820000
• Device Lot Number: 17072041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 07/31/2018; 11/30/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 08/02/2018; 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1