MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 HOOD; GOWN, SURGICAL

Catalog Number 0400800000

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 12/25/2018

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 investigation type have not yet been determined.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 debris in sterile package.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 received.  event confirmation status 2 reported events were confirmed; the cause traced to manufacturing.Evaluation results 2 devices were found to be affected by foreign material in sterile packaging.

Event Description

This report summarizes 2 malfunction events in which the device had debris in sterile package.2 events had no patient involvement; no patient impact.

• Brand Name: T4 HOOD
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8284711
• MDR Text Key: 134897992
• Report Number: 0001811755-2019-00242
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 04546540152626
• UDI-Public: 4546540152626
• 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
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0400800000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1