MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 23KHZ STRAIGHT HANDPIECE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C2600

Device Problem Output Problem (3005)

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

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This is 2 of 3 reports linked to mfg report numbers 3006697299-2023-00009 and 3006697299-2023-00011: a facility reported that during a neurosurgical procedure, the amplitude on the cusa excel 23khz straight handpiece (c2600) did not work.Additional information was later received indicating that the cusa device failed in the middle of the surgery and the procedure was stopped and rescheduled for 1 week later.The facility also stated that "it was difficult to tell the patient that the procedure was interrupted because of a failure of an instrument and that a second procedure needed to take place and that the aftercare also needed to be postponed." indication for use of the device was for a brain tumor.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 the cusa excel 23khz straight 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 - the investigation of the unit confirmed the complaint: evaluation verified customer information as valid.Evaluation verified customer information as valid.The transducer was found to be twisted in the handpiece housing.This was a user mistake, as the torque base was not used.The housing and all o-rings of the coil form were replaced, and the calibration and a full function test according to manufacturer specification has been performed.Root cause - the root cause has been confirmed as handpiece overtorqued due to incorrect assembly and disassembly of the handpiece by the customer using the torque wrench.This resulted in the torque wrench misaligning the dot on the handpiece and the handpiece.The ability for customers to execute the instructions as written in the current user manual and was verified by conducting a usability study.The risk remains acceptable.

Event Description

N/a.

• Brand Name: CUSA EXCEL 23KHZ STRAIGHT HANDPIECE
• Type of Device: ULTRASONIC SURGICAL PRODUCTS
• 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: 16301070
• MDR Text Key: 309524246
• Report Number: 3006697299-2023-00010
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K141674
• 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: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C2600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2005
• 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
• Patient Sex: Female