MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LENS INTEGRATED SYSTEM WIFI VERSION; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 72204354S

Device Problem Device Inoperable (1663)

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

Event Date 11/01/2017

Event Type  malfunction  

Event Description

It was reported that the screen was very yellow, white balance did not work.There was no a back up device available.There was no significant 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 exterior of the product and no physical damage was observed.The reported malfunction could not be duplicated during the functional testing process.All functions performed as expected.The complaint of yellow screen and white balance malfunction 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: LENS INTEGRATED SYSTEM WIFI VERSION
• 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: 7023072
• MDR Text Key: 92659260
• Report Number: 1643264-2017-01714
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

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: 72204354S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 12/13/2017
• 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: Reuse
• Patient Sequence Number: 1