MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 ZIPPER TOGA, XL; GOWN, SURGICAL

Catalog Number 0400850000

Device Problem Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2019

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: 4 events were reported for this quarter.Product return status: 4 device investigation types have not yet been determined.Additional information: 4 devices were labeled for single-use.4 devices were not reprocessed or reused.

Event Description

This report summarizes 4 malfunction events in which the device had material that was split, cut, or torn due to external or internal forces.4 events had patient involvement; no patient impact.

Event Description

This report summarizes 4 malfunction events in which the device had material that was split, cut, or torn due to external or internal forces.4 events had 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 4 previously reported events are included in this follow-up record.Product return status 4 devices were not available for evaluation.H3 other text : device not returned.

• Brand Name: T4 ZIPPER TOGA, XL
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9245088
• MDR Text Key: 173389351
• Report Number: 0001811755-2019-03415
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 34546540904509
• UDI-Public: 34546540904509
• Combination Product (y/n): N
• Number of Events Reported: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0400850000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1