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 Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).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 returned device and no issue was observed. a functional evaluation revealed the click feeling of each button is different and there was no live video output; only color bars were displayed.The complaint was confirmed. please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.

Event Description

It was reported that the camera head was damaged during sterilization process since a wrong method was used.No case involved.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.

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 returned device and no issue was observed.A functional evaluation revealed the click feeling of each button is different and there was no live video output; only color bars were displayed.The complaint was confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.

• 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
• MDR Report Key: 11484400
• MDR Text Key: 241480694
• Report Number: 1643264-2021-01007
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

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: 12/15/2020
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1