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

Model Number 72205058

Device Problem Unexpected Shutdown (4019)

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

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

It was reported that, during an arthroscopy surgery the lens 4k camera control unit was rebooting on its own.The procedure was completed using a competitor device.A delay greater than 30 minutes was reported.No further complications were reported.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during an arthroscopy surgery the lens 4k camera control unit was rebooting on its own.The procedure was completed using a competitor device.A delay greater than 30 minutes was reported.No further complications were reported.

Manufacturer Narrative

Serial number updated on d4.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 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.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include poor ventilation.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.

Manufacturer Narrative

Internal complaint reference case (b)(4).

Manufacturer Narrative

Internal complaint reference case (b)(4).

• 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: 13141827
• MDR Text Key: 285327362
• Report Number: 1643264-2022-00001
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885556720790
• UDI-Public: 00885556720790
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72205058
• Device Catalogue Number: 72205059
• Device Lot Number: FFB0685
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• 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: A
• Patient Sequence Number: 1