MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
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 device investigation types have not yet been determined.2 devices were labeled for single-use.2 devices were not reprocessed or 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.
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.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 2 previously reported events are included in this follow-up record.Product return status: 1 device was not available for evaluation.1 device investigation type has not yet been determined.
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.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h10.2 previously reported events are included in this follow-up record.Product return status.2 devices were not available for evaluation.H3 other text : product not available.
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.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h6, h10 2 previously reported events are included in this follow-up record.Product return status 2 devices were not available for evaluation.H3 other text : device discarded.

• Brand Name: FLYTE SURGICOOL TOGA, XL, PULLOVER
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 10748418
• Report Number: 0001811755-2020-02870
• Device Sequence Number: 11514857
• Product Code: FYA
• UDI-Device Identifier: 37613327117074
• UDI-Public: 37613327117074
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/29/2021

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 Number: 0408731000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020; 09/30/2020; 09/30/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 01/29/2021; 04/30/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1