MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL 3RD EDITION 660IMS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72200242S3E
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device displayed a reset date every time.Occurred during procedure.No delay was reported, no back-up device was available.
Additional Manufacturer Narrative
There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of product and no damage was observed.Complaint of wrong time stamp was confirmed.Unit did power up and pass functional testing but all prints were labeled with 01/01/2001 time stamp.Reason for wrong time stamp is low voltage output (.6 volts) on the mother board's cmos battery (3 volt battery).Investigator has concluded the cause of the time stamp failure to be a dead cmos battery.Time stamp was corrected after a new cmos battery was installed.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: SVCE REPL 3RD EDITION 660IMS
• 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: 7690260
• Report Number: 1643264-2018-00535
• Device Sequence Number: 920389
• Product Code: GCJ
• UDI-Device Identifier: 00885554030846
• UDI-Public: (01)00885554030846
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

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: 72200242S3E
• Device Catalogue Number: 72200242S3E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1