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

Model Number	72205059
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a meniscectomy surgery, the camera head stops transmitting the image uncontrolled.The procedure was completed with a significant delay using a back-up device.Additional anesthesia was required.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The reported device, used in treatment, 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 device and no deficiencies were observed.The reported malfunction was not observed during functional evaluation.No loss of image was observed.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.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors, unrelated to the manufacturing and design of the device that could have contributed to the reported event, include issues with a concomitant device.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
• 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: 12257335
• Report Number: 1643264-2021-02237
• Device Sequence Number: 19749939
• Product Code: GCJ
• UDI-Device Identifier: 00885556720844
• UDI-Public: 00885556720844
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 08/01/2021
• Supplement Report FDA Received Date: 11/18/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown