MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) EXCEL 36KHZ STRAIGHT HANDPIECE EACH1; Instrument, ultrasonic surgical

Model Number C2602

Device Problems Overheating of Device (1437); Output Problem (3005)

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

Event Type  malfunction  

Event Description

A facility returned the cusa excel 36khz straight handpiece each1 (c2602) for "no output and loss of m-power" issue.During testing of the handpiece by an integra technician, it was observed that between the transducer and housing, the top lip of the housing melted due to faulty transducer and the heating of the device.There was no patient involvement or user injury.

Manufacturer Narrative

The excel 36khz straight handpiece each1 (c2602) was returned for evaluation: device history record (dhr): the dhr documentation was reviewed and no anomalies during the manufacture or packaging that could be associated with the complaint incident was observed.Failure analysis - investigation of the returned device showed that the q-power was very high, the stroke small, and housing damage due to heating and faulty transducer.The transducer, housing and o-rings were replaced to resolve all issues.Root cause - the root cause was confirmed as transducer delamination because of transducer braze degrading in the field.Additionally, the device had a defective cooling system due to blockage/kink in the tubing causing the handpiece to overheat.Corrective action was raised specific to 36khz handpiece c2602 and transducers which involves braze material from supplier was incorrect and contained zinc.The risk remains acceptable.For further information relating to the handpiece and torquing procedure, please consult: excel handpiece ifu available online at integra.Com.

• Brand Name: EXCEL 36KHZ STRAIGHT HANDPIECE EACH1
• Type of Device: Instrument, ultrasonic surgical
• 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: 17225006
• MDR Text Key: 318205316
• Report Number: 3006697299-2023-00074
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10381780039433
• UDI-Public: 10381780039433
• Combination Product (y/n): N
• PMA/PMN Number: K141674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2602
• Device Catalogue Number: C2602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2018
• 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