MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CAMERA CONTROL UNIT HIGH DEF 560P; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72201919
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that the camera control unit high def 560p had a socket problem and there was flickering find on the monitor.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10, h6: the reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include residue on the camera port connections.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 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.A complaint history review concluded this was a repeat issue.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10, h3, h6: the reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.Product failed functional testing with intermittent and flickering video output.Cause of video output malfunctions is a defective camera head receptacle.Receptacle is worn causing intermittent contact with edge card.The complaint was confirmed and the root cause has been determined to be a worn receptacle.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.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.

• Brand Name: CAMERA CONTROL UNIT HIGH DEF 560P
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11513634
• Report Number: 1643264-2021-01067
• Device Sequence Number: 17101221
• Product Code: GCJ
• UDI-Device Identifier: 03596010643094
• UDI-Public: 03596010643094
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K070266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2021

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: 72201919
• Device Catalogue Number: 72201919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/25/2021; 06/08/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 03/27/2021; 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1