MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP FLYTE SURGICOOL TOGA, XL, PULLOVER; GOWN, SURGICAL

Catalog Number 0408731000

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2020

Event Type  malfunction  

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 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 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.

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 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.

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 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.

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
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 10748418
• MDR Text Key: 213467664
• Report Number: 0001811755-2020-02870
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 37613327117074
• UDI-Public: 37613327117074
• Combination Product (y/n): N
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0408731000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1