MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LENS 4K CCU WIFI VERSION; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 72205059

Device Problems Connection Problem (2900); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that, during an acl surgery, the lens 4k console would restart automatically and the monitor would flicker while connecting the camera head to the console.The procedure was completed with a competitor device and a delay greater than 30 minutes was reported.No further complications were reported.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A complaint history review concluded this was a repeat issue.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.A relationship, if any, between the subject device and the reported event could not be determined.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event potentially include residue on the camera port connections, power source or power supply issues, system power up configuration settings.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection was performed and observed residue on the camera head port contacts.A functional evaluation revealed video noise in live video when the head connector is moved.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.It was determined the device did not contribute to the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event potentially include use of a damp camera head cable.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: LENS 4K CCU WIFI VERSION
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12360262
• MDR Text Key: 267891061
• Report Number: 1643264-2021-02273
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885556720844
• UDI-Public: 00885556720844
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K191177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72205059
• Device Catalogue Number: 72205059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• 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: Unknown
• Patient Sequence Number: 1