MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE CCU HIGH DEF 560P 2NDGEN; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72201919S
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the camera control unit was not capturing images.It is unknown whether the event happened during surgery and if there was patient involvement and if there was a back-up device available or if there was a delay.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h2, h3, h6.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 and no deficiencies were observed.A functional test revealed the usb drive was not recognized.Images are displayed but can not be saved to the usb drive.The complaint was confirmed and the root cause was associated with component failure.A review of manufacturing records found the device has been in service for over 5 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 an isolated event.

• Brand Name: SERVICE CCU HIGH DEF 560P 2NDGEN
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10835455
• Report Number: 1643264-2020-01815
• Device Sequence Number: 19708375
• Product Code: GCJ
• UDI-Device Identifier: 03596010645517
• UDI-Public: 03596010645517
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K070266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2020

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: 72201919S
• Device Catalogue Number: 72201919S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1