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.Replaced ccu 4 times (4 ccus failed) and camera head, light cable, scopes all have been changed and check condition is fully good.However still yellow image shows up.No patient injury was reported.Back up was used to complete the procedure.A delay greater than 30 minutes was reported.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history record shows there are 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: 7844097
• Report Number: 1643264-2018-00664
• Device Sequence Number: 2507812
• 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): 10/30/2018

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?: No
• Initial Date Received by Manufacturer: 08/12/2017
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1