MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UHD 4K FLAT PANEL DISPLAY LCD SONY 31"; ENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENT

Model Number	LMD-X310MD
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that the uhd 4k flat panel display lcd (b)(6) 31" was flickering and had an orange spot in the middle of the screen.The procedure was successfully completed without delay.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the lot did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A visual inspection was performed and no deficiencies were observed.The reported malfunction was not observed during functional evaluation.The complaint was not confirmed.No containment or corrective actions are recommended at this time.

• Brand Name: UHD 4K FLAT PANEL DISPLAY LCD SONY 31"
• Common Device Name: ENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11616898
• Report Number: 1643264-2021-01268
• Device Sequence Number: 19807807
• Product Code: PEA
• UDI-Device Identifier: 04548736013940
• UDI-Public: 04548736013940
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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: LMD-X310MD
• Device Catalogue Number: 72205011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1