MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE SURGICOOL TOGA, 2XL, ZIPPER, PEELAWAY; GOWN, SURGICAL

Catalog Number 0408841100

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

Device discarded by user.

Event Description

It was reported that during a surgical procedure at the user facility, patient fluid soaked through the surgical tech's toga.The procedure was completed successfully with the same device without a delay.There were no adverse consequences or medical intervention with this procedure.

• Brand Name: FLYTE SURGICOOL TOGA, 2XL, ZIPPER, PEELAWAY
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6521805
• MDR Text Key: 73739422
• Report Number: 0001811755-2017-00882
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 7613327117158
• UDI-Public: (01)7613327117158(17)200101(10)17010026
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 0408841100
• Device Lot Number: 17010026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1