MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE REPLACEMENT 4K A/C CAMERA HEAD; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	72205058S
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the returned device and no issue was found.Functional evaluation revealed the camera head is recognized and switches from a color bars to a blank screen with blue hues on the left side of the screen.White balancing was successful but the hues remain and there is no live image.The complaint was confirmed and the root cause has been associated with an electrical component failure.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include a failed image sensor or cable.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.
Event or Problem Description
It was reported that, the "camera head" had a blue screen.No case reported; therefore, there was no patient involvement.Results of investigation have concluded that this unit has no live image which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: SERVICE REPLACEMENT 4K A/C CAMERA HEAD
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10579497
• Report Number: 1643264-2020-01277
• Device Sequence Number: 2627289
• Product Code: GCJ
• UDI-Device Identifier: 00885556757017
• UDI-Public: 885556757017
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K191177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2020

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 Catalogue Number: 72205058S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1