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

Model Number	72200561S
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the camera head was not capturing images.No case reported; therefore, there was no patient involvement.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 on the product and no issue was observed.Complaint of capture failure was confirmed.Product failed functional testing with no button activation when pressed.Cause of capture malfunction is the flex cable from camera pcb to button assembly was not connected.The complaint of capture malfunction was confirmed and the root cause has been determined to be a disconnected flex cable to button assembly.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: 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: 10680595
• Report Number: 1643264-2020-01517
• Device Sequence Number: 2962266
• Product Code: GCJ
• UDI-Device Identifier: 03596010606808
• UDI-Public: 03596010606808
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070266
• 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,Followup
• Report Date (Section B): 11/05/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1