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

Model Number	72201919S
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that the display of the high def 560p sometimes blacked out and the button had no good response.No case involved.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 received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed and corrosion on the head port connector contacts was observed.A functional test revealed video noise when the camera cable connector was moved.The complaint was verified.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include the use of wet cable connectors.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.

• 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: 11456791
• Report Number: 1643264-2021-00956
• Device Sequence Number: 3117563
• Product Code: GCJ
• UDI-Device Identifier: 03596010645517
• UDI-Public: 03596010645517
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: No Information
• Device Model Number: 72201919S
• Device Catalogue Number: 72201919S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1