MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LENS INTEGRATED SYSTEM NON-WIFI VERSION; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72204685
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that since lens system installed, yellow tinted image show up occasionally.The device was test with different devices and the issue persists.A significant delay was reported.The procedure was completed with a backup device.
Additional Manufacturer Narrative
The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of the product and no physical damage was observed.The reported complaint of yellow tinted image could not be duplicated during the functional testing process.Ccu passed all functional testing and 4 hour burn-in inside of test tower.All video outputs and functions performed as expected.The complaint of yellow tint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

• Brand Name: LENS INTEGRATED SYSTEM NON-WIFI VERSION
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7768914
• Report Number: 1643264-2018-00593
• Device Sequence Number: 11153288
• Product Code: GCJ
• UDI-Device Identifier: 00885556617908
• UDI-Public: (01)00885556617908
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K153606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018

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: 72204685
• Device Catalogue Number: 72204685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 08/12/2017
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1