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

Model Number 72204354

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/06/2018

Event Type  malfunction  

Event Description

It was reported the system failed during procedure.All lights went out and could not be restored.System had to be replaced.Surgeon had to convert a mini open procedure from arthroscopic which resulted in delays and larger surgical incision.

Manufacturer Narrative

The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.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.

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 product and no issue was observed.Complaint of power failure was confirmed.Cause of failure was the neutral wire from power supply was unplugged from terminal on the power entry module (pem).Unit passed functional testing after the wire was reseated on the terminal on the pem.The wire appeared to not be clamped down tight on terminal and may have become unseated over time.The complaint investigation has concluded that power failure was caused by an unseated wire from power supply to pem.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: 7304653
• MDR Text Key: 101347152
• Report Number: 1643264-2018-00180
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885556617878
• UDI-Public: (01)00885556617878
• Combination Product (y/n): N
• PMA/PMN Number: K153606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2018

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: 72204354
• Device Catalogue Number: 72204354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 03/30/2018; 06/04/2018
• Supplement Dates FDA Received: 04/09/2018; 06/06/2018
• 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: Reuse
• Patient Sequence Number: 1