MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CAMERA HEAD LENS INT SYS; ARTHROSCOPE

Catalog Number 72203967

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/1901

Event Type  malfunction  

Event Description

It was reported that during shoulder scope, the device was whiting out.A backup device was available to complete the procedure with no delay or patient injuries.

Manufacturer Narrative

The device 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 live video output malfunction was confirmed.Cause of video malfunction is a defective cable assembly.Camera head passed functional testing with a known good cable assembly installed.The complaint investigation has concluded that the root cause of malfunction is a defective cable 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: CAMERA HEAD LENS INT SYS
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8884341
• MDR Text Key: 154000057
• Report Number: 1643264-2019-00532
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00885556629833
• UDI-Public: 00885556629833
• Combination Product (y/n): N
• PMA/PMN Number: K153606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 72203967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 09/24/2019
• Supplement Dates FDA Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1