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

Catalog Number	72200561F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device has image interference with completely loss of image.The procedure was successfully completed with the same device, there is not critical delay or serious injury.
Additional Manufacturer Narrative
The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of blank live image could not be reproduced.Product passed functional testing during 6 hour burn-in with no signal loss or interference.Video image remained constant throughout burn-in.All functions perform as expected.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.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.

• Brand Name: RFB, 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 6512
• MDR Report Key: 8065082
• Report Number: 1643264-2018-00863
• Device Sequence Number: 19371538
• Product Code: GCJ
• UDI-Device Identifier: 03596010608710
• UDI-Public: 03596010608710
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K070266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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 Catalogue Number: 72200561F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1