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

Catalog Number 0408741000

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2019

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 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 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.

• Brand Name: FLYTE SURGICOOL TOGA, 2XL, PULLOVER
• 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: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 8545829
• MDR Text Key: 143713710
• Report Number: 0001811755-2019-01338
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 37613327117081
• UDI-Public: 37613327117081
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0408741000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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