MAUDE Adverse Event Report: SURGICAL INNOVATIONS LTD YELLOPORT ELITE; HASSON ADAPTOR 10MM

Model Number	EA10NH
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device with incorrect sterility status discovered during containment activity at manufacturer (surgical innovations ltd) during investigations of customer complaint (b)(4).Devices are marked as 'sterile' single-use but are non-sterile reusable.
Additional Manufacturer Narrative
Final report for (b)(4) attached plus fsns sent to customers when the incident was discovered.
Additional Manufacturer Narrative
Final report for (b)(4) attached plus fsns sent to customers when the incident was discovered.Corrected to report to change status to final from initial as the final report is attached.
Event or Problem Description
Device with incorrect sterility status discovered during containment activity at manufacturer (surgical innovations ltd) during investigations of customer complaint (b)(4).Devices are marked as 'sterile' single-use but are non-sterile reusable.

• Brand Name: YELLOPORT ELITE
• Common Device Name: HASSON ADAPTOR 10MM
• Manufacturer (Section D): SURGICAL INNOVATIONS LTD; clayton wood house; 6 clayton wood bank; leeds, west yorkshire LS16 6QZ; UK LS16 6QZ
• Manufacturer (Section G): SURGICAL INNOVATIONS LTD; clayton wood house; clayton wod bank; leeds, west yorkshire LS16 6QZ; UK LS16 6QZ
• Manufacturer Contact: stephen seed ; clayton wood house; 6 clayton wood bank; leeds, west yorkshire LS16 -6QZ ; UK LS16 6QZ
• MDR Report Key: 13659006
• Report Number: 9680952-2022-00004
• Device Sequence Number: 6427753
• Product Code: GCJ
• UDI-Device Identifier: 05051986012117
• UDI-Public: 05051986012117
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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: EA10NH
• Device Lot Number: 734029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• 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