MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC CAMERA HEAD NON-AC HD560H; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72200561S
Medical Device Problem Code	Optical Obstruction (3002)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the camera head was having flickering issues.No case was involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The reported device, intended for use in treatment, was returned to the designated complaint unit for independent evaluation.There was no relationship found between the returned device and the reported incident.Visual inspection of the returned device did not identify any issues.Functional evaluation did not reveal any problems.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.The device has been in service for over five years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.

• Brand Name: SVC CAMERA HEAD NON-AC HD560H
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10804906
• Report Number: 1643264-2020-01719
• Device Sequence Number: 2849597
• Product Code: GCJ
• UDI-Device Identifier: 03596010606808
• UDI-Public: 03596010606808
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K070266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: 72200561S
• Device Catalogue Number: 72200561S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1