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

Model Number 72200242F

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2017

Event Type  malfunction  

Event Description

It was reported by customer that device did not hold date/time.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: RFB, 660 HD IMAGE MANAGEMENT SYSTEM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: james gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7132810
• MDR Text Key: 95641631
• Report Number: 1643264-2017-01834
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 03596010608994
• UDI-Public: (01)03596010608994
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

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
• Device Operator: Health Professional
• Device Model Number: 72200242F
• Device Catalogue Number: 72200242F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 12/20/2017
• Supplement Dates FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1