MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL W/ CONSOLE 220V AC WITH FOOTSWITCH; ULTRASONIC SURGICAL PRODUCTS

Catalog Number CUSAEXCEL9

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 1 of 3 reports linked to mfg report numbers 3006697299-2023-00010 and 3006697299-2023-00011: a facility reported that during a neurosurgical procedure, the amplitude on the cusa excel w/ console 220v ac with footswitch (cusaexcel9) 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

The cusaexcel w/ console (cusaexcel9) was returned for evaluation: device history record (dhr) ¿ the dhr was reviewed and the following anomalies that could be associated with the complaint incident were observed but have been deemed not related to complaint incident: testing of ultrasonic and machine control display pcb's during manufacture; ncr was initiated for cosmetic failure during the manufacture, scratch found on top cover; deemed not related to complaint incident.Failure analysis - evaluation was unable to conclusively verify customer information as valid.The device passed all cosmetic and functional testing and meets specification.Root cause - the root cause was confirmed as no fault found.The device was found to meet specification.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: CUSA EXCEL W/ CONSOLE 220V AC WITH FOOTSWITCH
• 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: 16301081
• MDR Text Key: 309528078
• Report Number: 3006697299-2023-00009
• 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: CUSAEXCEL9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2017
• 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