MAUDE Adverse Event Report: SMITH & NEPHEW, INC. IMAGE MANAGEMENT SYSTEM 660HD-E; DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL

Catalog Number 72204668

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during a procedure, when the right camera button was pressed to record, it was going to white balance settings instead.It was brought in a different camera head to test if that was where the default was and it was not.The image management system began taking videos without assistance one after the other.It would not come off of recording nor would it allow to cancel or close out of anything.The procedure was completed with a back up device.There was a delay greater than 30 minutes and no further complications were reported.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual inspection did not reveal any issues.A functional evaluation was performed on the returned device and did not find any malfunction.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include issues during setup of the device.No containment or corrective actions are recommended at this time.

• Brand Name: IMAGE MANAGEMENT SYSTEM 660HD-E
• Type of Device: DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18818396
• MDR Text Key: 336683077
• Report Number: 1643264-2024-00139
• Device Sequence Number: 1
• Product Code: LMB
• UDI-Device Identifier: 00885556623695
• UDI-Public: 00885556623695
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72204668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1