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

Model Number	72204354
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that during use in an arthroscopic knee surgery, on the lens integrated system appears as a yellow sort of haze on screen, producing a screen image not recognizable and not allowing the surgery to continue.No patient injury or other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).D4: updated part, serial and udi number.
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 review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.Visual inspection of the customer provided image shows a vulcan unit with voltage calibration failure displayed on the screen.Visual inspection observed no issues.Functional evaluation revealed no issues.The complaint was confirmed but the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Device movement and shipment could have changed the conditions that caused the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: LENS INTEGRATED SYSTEM NON-WIFI VERSION
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11924359
• Report Number: 1643264-2021-02044
• Device Sequence Number: 11860884
• Product Code: GCJ
• UDI-Device Identifier: 00885556617908
• UDI-Public: 00885556617908
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K153606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72204354
• Device Catalogue Number: 72204685
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/08/2021; 07/01/2021; 10/04/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/14/2021; 07/06/2021; 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other