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

Model Number 72203967

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Manufacturer Narrative

The reported device, intended for use in treatment, was returned to the designated complaint unit for independent evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the returned device did not identify any issues.Functional evaluation revealed there was no live video output.The complaint has been confirmed and the root cause has been associated with an electrical component failure.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include a failed image sensor.A review of the device history records showed there were no indications to suggest that the lot did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.

Event Description

It was reported that during set up and inspection, the camera lens was blurry; there is no information regarding how the procedure was completed.No patient injury or other complications were reported.Results of investigation have concluded that this unit had no live video output which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• 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
• 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: 11488709
• MDR Text Key: 240401863
• Report Number: 1643264-2021-01015
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00885556629833
• UDI-Public: 00885556629833
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K153606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2021

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
• Device Operator: Health Professional
• Device Model Number: 72203967
• Device Catalogue Number: 72203967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/15/2021
• 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