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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2019

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: 5 events were reported for this quarter.Product return status: 2 devices were not available for evaluation.3 device investigation type has not yet been determined.Additional information: 5 devices were labeled for single-use.5 devices were not reprocessed and reused.

Event Description

This report summarizes 5 malfunction events in which the device had material that was split, cut, or torn due to external or internal forces.3 events had no patient involvement; no patient impact.2 events had patient involvement; no patient impact.

Event Description

This report summarizes 5 malfunction events in which the device had material that was split, cut, or torn due to external or internal forces.3 events had no patient involvement; no patient impact.2 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: 5 previously reported events are included in this follow-up record.Product return status 2 devices were received.3 devices were not available for evaluation.Event confirmation status 2 reported events were confirmed.Evaluation results 2 devices did not have a root cause established.

• 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: 8816153
• MDR Text Key: 152099739
• Report Number: 0001811755-2019-02382
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 34546540904509
• UDI-Public: 34546540904509
• Combination Product (y/n): N
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

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
• Device Operator: No Information
• Device Catalogue Number: 0400850000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1