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

Model Number C7023

Device Problem Temperature Problem (3022)

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

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

The cusa clarity handpiece was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies hat could be associated with the complaint incident was observed.Reported failure of temperature issue during sterilization was unconfirmed.The device was manufactured in (2020).Review of service history confirmed this is the 1st service.Corrective action was unable to be implemented as the device was not returned for evaluation.Based on the reported failure of "temperature issue during sterilization", further information was requested.No response to questions was received.There is insufficient information available to determine exact root cause but based on report provided by customer, the methodology used to sterilize the device deviates from that stipulated in the device ifu.However, a complete investigation into root cause is unable to be completed at this time.Should the device be returned for analysis the complaint will be reopened and an investigation will be completed.In the interim, we have recommended the following: customer to provide answer to questions requested to assist understanding of issue and sterilization methodology used.Customer to reference device ifu and reference sections relating to sterilization procedure.At present, we consider this complaint to be closed.

Event Description

This is 1 of 2 reports linked to mfg report number 3006697299-2022-00053: a facility reported that during revalidation of autoclaves, the cusa clarity 23 khz handpiece (c7023) were tested, and 7 tests on the same instrument showed that the temperature in the instrument's lumen did not reach the correct temperature for sterilization (134 degrees for 4 minutes) in relation to danish and eu standards.The temperature only reached132 degrees as maximum temperature in a very short time.The device was already used on patient was this was discovered, thus there was no patient injury or increased surgery time.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14105188
• MDR Text Key: 291406135
• Report Number: 3006697299-2022-00054
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10381780466314
• UDI-Public: (01)10381780466314
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C7023
• Device Catalogue Number: C7023
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2022
• Date Device Manufactured: 08/05/2020
• 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