MAUDE Adverse Event Report: SURGICAL INNOVATIONS LTD YELLOPORT ELITE; 12X75 PENCIL POINT TROCAR

Model Number	ET1207503
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After receipt, the customer found that the device was labelled "sterile r", with a due date, and disposable symbol on the label despite non sterile device.
Additional Manufacturer Narrative
Corrected data to "initial" from "5 day.".
Event or Problem Description
After receipt, the customer found that the device was labelled "sterile r", with a due date, and disposable symbol on the label despite non sterile device.
Event or Problem Description
After receipt, the customer found that that the device was labelled "sterile r", with a due date, and disposable symbol on the label despite non sterile device.
Additional Manufacturer Narrative
Corrected data to "initial" from "5 day".Attached final report from the investigation.

• Brand Name: YELLOPORT ELITE
• Common Device Name: 12X75 PENCIL POINT TROCAR
• Manufacturer (Section D): SURGICAL INNOVATIONS LTD; clayton wood house; clayton wood bank; leeds, west yorkshire LS16 6QZ; UK LS16 6QZ
• Manufacturer (Section G): SURGICAL INNOVATIONS LTD; clayton wood house; clayton wood bank; leeds, west yorkshire LS16 6QZ; UK LS16 6QZ
• Manufacturer Contact: stephen steve ; clayton wood house; clayton wood bank; leeds, west yorkshire LS16 -6QZ ; UK LS16 6QZ
• MDR Report Key: 13265044
• Report Number: 9680952-2022-00002
• Device Sequence Number: 17657889
• Product Code: GCJ
• UDI-Device Identifier: 05051986012438
• UDI-Public: 05051986012438
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2022

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
• Operator of Device: Health Professional
• Device Model Number: ET1207503
• Device Lot Number: 735479
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 01/13/2022; 01/13/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 02/25/2022; 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown