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

Catalog Number	72200242S3E
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during shoulder surgery the device rebooted.The procedure was completed with a backup device with no delay or patient injury reported.
Additional Manufacturer Narrative
The device was received for evaluation.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 boot up failure was confirmed.Unit did fail during boot up with error message to start product up in normal mode.Cause of errors is corrupted software.The error could be caused if the system stopped responding, crashed, or lost power unexpectedly.The complaint investigation has concluded the cause of the failure to be a software error and hdd needs to be recloned.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: 8160746
• Report Number: 1643264-2018-00987
• Device Sequence Number: 16661363
• Product Code: GCJ
• UDI-Device Identifier: 00885554030846
• UDI-Public: 00885554030846
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K060777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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 Catalogue Number: 72200242S3E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1