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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE SURGICOOL TOGA, 2XL, PULLOVER; GOWN, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO FLYTE SURGICOOL TOGA, 2XL, PULLOVER; GOWN, SURGICAL Back to Search Results
Catalog Number 0408741000
Medical Device Problem Code Material Split, Cut or Torn (4008)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 01/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 2 events were reported for this quarter.Product return status: 2 devices were received.Event confirmation status: 2 reported events were confirmed; the cause traced to user.Evaluation results: 2 devices were found to be affected by a stress problem.Additional information: 2 devices were labeled for single-use.2 devices were not reprocessed and reused.
 
Event or Problem Description
This report summarizes 2 malfunction events in which the device had material that was split, cut, or torn due to external or internal forces.2 events had no patient involvement; no patient impact.
 
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Brand Name
FLYTE SURGICOOL TOGA, 2XL, PULLOVER
Common Device Name
GOWN, SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8545829
Report Number0001811755-2019-01338
Device Sequence Number1744271
Product Code FYA
UDI-Device Identifier37613327117081
UDI-Public37613327117081
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/24/2019
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 No Information
Device Catalogue Number0408741000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/01/2019
Initial Report FDA Received Date04/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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