MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY 36KHZ HANDPIECE

Catalog Number C7036

Device Problem Output Problem (3005)

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

Event Date 11/16/2021

Event Type  malfunction  

Event Description

This report is 2 of 3 linked to mfg report numbers 3006697299-2021-00063 and 3006697299-2021-0006: a facility reported that after 30 minutes of use, the cusa clarity 36khz handpiece did not perform the requested amplitude.There was no output of power, and when tip validation test was performed "error" was shown.After switching to a 2nd 36khz handpiece, the error appeared again in the exact same manner.They then had to change to a 23khz handpiece which seemed to be working fine even after 30 minutes.No patient injury or death is alleged, but the event led to increased surgery time of 30 minutes.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The cusa clarity handpiece was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - evaluation was unable to conclusively verify customer information as valid.The problem as described could not be reproduced.Root cause - the root cause was confirmed as no fault found.The reported failure ¿clarity with not output power¿ was unconfirmed.The root cause was confirmed as no fault found.The device met specification and passed all testing.No further investigation required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.

• Brand Name: CUSA CLARITY 36KHZ 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: 12965137
• MDR Text Key: 286928172
• Report Number: 3006697299-2021-00064
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K161882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C7036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2019
• 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