MAUDE Adverse Event Report: SURGICAL INNOVATIONS LTD YELLOPORT ELITE; HASSON ADAPTOR 12MM

Model Number	EA12NH
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer complained that the device was now labelled as ']single-use' whereas previous purchases of the same device had not been labelled as 'single-use'.
Additional Manufacturer Narrative
Initial report of incident.
Event or Problem Description
Customer complained that the device was now labelled as 'single-use' whereas previous purchases of the same device had not been labelled as 'single-use'.
Additional Manufacturer Narrative
Final report for incident: (b)(4).

• Brand Name: YELLOPORT ELITE
• Common Device Name: HASSON ADAPTOR 12MM
• 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: 12728365
• Report Number: 9680952-2021-00035
• Device Sequence Number: 4350707
• Product Code: GCJ
• UDI-Device Identifier: 05051986012117
• UDI-Public: 05051986012117
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

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: EA12NH
• Device Lot Number: 734028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown