MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY 23 KHZ HANDPIECE

Catalog Number C7023

Device Problem Output Problem (3005)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that when the surgeon handed the cusa handpiece (c7023) to the nurse during an unspecified procedure, the surgeon handed the handpiece to the nurse while stepping on the footswitch and the nurse was burned.The surgeon did not notice that he/she kept on stepping on it because there was no sound when outputting the footswitch.Same device was used to complete the procedure.No further adverse impact to users or patient was reported and it is unknown if there was surgical delay.Additional information has been requested.

Manufacturer Narrative

The cusa clarity 23 khz handpiece (c7023) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.However, based on the information provided by the customer, "when handing the handpiece from the doctor to the nurse during procedure, the doctor handed it while stepping on the foot switch, and the nurse was burned", we surmise that this issue occurred due to user error.As a corrective action, we recommend training per ifu (instructions for use) which states "when the handpiece is connected to a cusa clarity system that is powered on, but the handpiece is not in use, keep the handpiece away from the patient.Place the handpiece on a sterile, flat, dry, nonconductive, and highly visible surface." furthermore "touching the tip of the handpiece by the user, while the handpiece is powered on, may result in personal injury.".

• Brand Name: CUSA CLARITY 23 KHZ HANDPIECE
• Type of Device: CUSA CLARITY
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• MDR Report Key: 11824434
• MDR Text Key: 260214936
• Report Number: 3006697299-2021-00017
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K182809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C7023
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: C7000 CUSA CLARITY CONSOLE; C7401S CUSA TIP