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

Catalog Number 72200242F

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/15/2018

Event Type  malfunction  

Event Description

It was reported that device would not take photos continuously.Photos had to be taken with a mobile phone instead as no backup was readily available.No major delay or patient injury was reported.

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 would not take photos continuously could not be reproduced.Unit passed functional testing during 6 hour burn-in.Video stills and clips were taken continuously during 6 hour burn-in.All video inputs/outputs normal and all functions performed as expected.Unit was tested in both pal and ntsc formats and both analog and digital video outputs.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: 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: jim gonzales ; 7000 w. william cannon drive; austin, TX 78735
• MDR Report Key: 7421715
• MDR Text Key: 105305261
• Report Number: 1643264-2018-00278
• Device Sequence Number: 1
• Product Code: GCJ
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

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 Catalogue Number: 72200242F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/11/2018
• Supplement Dates Manufacturer Received: 05/01/2018
• Supplement Dates FDA Received: 05/04/2018
• 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