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

Model Number	72205059
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the lens 4k controller started to smell after about 30 min and the light went out.After a restart, it ran briefly and then the system dropped out completely.The device overheated and became hot to the touch.Once the system cooled down, it worked again.The incident occurred while setting-up for the procedure.A back-up device was available, no surgical delay reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the lens 4k controller started to smell after about 30 min and the light went out.After a restart, it ran briefly and then the system dropped out completely.The device overheated and became hot to the touch.Once the system cooled down, it worked again.The incident occurred while setting-up for the procedure.A back-up device was available, no surgical delay reported.
Event or Problem Description
It was reported that, during procedure, the lens 4k controller started to smell after about 30 min and the light went out.After a restart, it ran briefly and then the system dropped out completely.The device overheated and became hot to the touch.Once the system cooled down, it worked again.A back-up device was available, no surgical delay reported.No other complication were reported.
Additional Manufacturer Narrative
H10: additional information on b4.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A smith & nephew service center visual evaluation of the returned device did not identify any issues.A smith & nephew service center functional evaluation revealed a light output fault.It was determined the device contributed to the reported event.The complaint was confirmed and the root cause was associated with component failure.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.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.No containment or corrective actions are recommended at this time.

• Brand Name: LENS 4K CCU WIFI VERSION
• Common Device Name: 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: 13585295
• Report Number: 1643264-2022-00061
• Device Sequence Number: 12167085
• Product Code: GCJ
• UDI-Device Identifier: 00885556720844
• UDI-Public: 00885556720844
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K191177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2022

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
• Operator of Device: Health Professional
• Device Model Number: 72205059
• Device Catalogue Number: 72205059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 02/23/2022; 05/05/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 02/25/2022; 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown