MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL 660 HD IMAGE MANAGEMENT SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72200242S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the screen goes blank after the doctor takes the picture.A backup device was available to complete the procedure with no delay or patient injuries.
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 product and no issue was observed.Complaint of blank screen after capturing a picture could not be reproduced.Unit passed functional testing during 6 hour burn-in including capture and print function.Display touchscreen did not blank out after pictures were captured.All video inputs/outputs normal and unit's display performed as expected.Both analog and digital video outputs were tested during burn-in.The complaint 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: SVC REPL 660 HD IMAGE MANAGEMENT SYSTEM
• 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: 7553439
• Report Number: 1643264-2018-00425
• Device Sequence Number: 16747416
• Product Code: GCJ
• UDI-Device Identifier: 03596010581327
• UDI-Public: (01)03596010581327
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K060777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

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: 72200242S
• Device Catalogue Number: 72200242S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1