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

Model Number	72204354
Medical Device Problem Code	Optical Discoloration (2999)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use, the color image of the lens integrated system was wobbling, there was complete color change in the monitor.The procedure was completed with the same device.There was a delay greater than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H10: h3, h6: the reported device was not returned to the designated complaint facility for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include failure of 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 reoccurrence 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 found similar reported events.A risk management review found that the reported failure was documented appropriately.There were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.H11: corrected data g2 (company representative should be checked).

• Brand Name: LENS INTEGRATED SYSTEM 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: 14497769
• Report Number: 1643264-2022-00179
• Device Sequence Number: 12170871
• Product Code: GCJ
• UDI-Device Identifier: 00885556617878
• UDI-Public: 00885556617878
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K153606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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: 72204354
• Device Catalogue Number: 72204354R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 08/16/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown