MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 660 HD IMS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 72200242

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/04/2018

Event Type  malfunction  

Event Description

It was reported that the device causes the light to dim.No back-up device was available.Nor delay or patient injury 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 dim light could not be reproduced.Unit passed functional testing during 6 hour burn-in including capture and print function.Unit did not dim the lighting in the video pics and clips during burn-in.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: 660 HD IMS
• 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 west william cannon drive; austin, TX 78735
• MDR Report Key: 7551102
• MDR Text Key: 109567673
• Report Number: 1643264-2018-00421
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 03596010566676
• UDI-Public: (01)03596010566676
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200242
• Device Catalogue Number: 72200242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1