MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SONY 27 MONITOR; ACCESSORIES,ARTHROSCOPIC

Model Number	LMD-2760MD
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during the set up before the surgery the sony 27 monitor is powered on, the screen has lines across, as per this issue, the staff was unable to view images.No patient injuries or delay reported.Smith and nephew back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h2, h3, h6.The reported device, intended for use in treatment, was received for evaluation.There was a 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 product 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.A functional test revealed that the monitor powers up but displays red lines in place of an image.The complaint was verified and the root cause was associated with electrical component failure.

• Brand Name: SONY 27 MONITOR
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10932738
• Report Number: 1643264-2020-01983
• Device Sequence Number: 16748828
• Product Code: NBH
• UDI-Device Identifier: 04905524983111
• UDI-Public: 04905524983111
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2021

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-2760MD
• Device Catalogue Number: 72204860
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 01/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1