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

Model Number	72200561S
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the camera head had no output image.No case reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
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 noted worn contacts on the connector.There was film inside the lens.Functional evaluation revealed dark image display.There was no live video output.The complaint has been confirmed and the root cause has been associated with an electrical component failure.Factors that could have contributed to the reported event include a failed image sensor.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.

• 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: 10778393
• Report Number: 1643264-2020-01684
• Device Sequence Number: 3509958
• Product Code: GCJ
• UDI-Device Identifier: 03596010606808
• UDI-Public: 03596010606808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1