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 Injury (2348)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

The device was returned for evaluation.The device was assembled and attached to the console.When the system was powered on, after failing to circulate the cooling water the coolant warning light came on and the system would no longer go through the startup procedure.The device history record (dhr) documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.The reported complaint was confirmed.Root cause was due to a defective coliform.

Event Description

A general surgery coordinator reported that on (b)(6) 2020, the device c2600 cusa excel 23khz straight handpiece was assembled and attached to the console for a liver resection procedure.When the system was powered on, after failing to circulate the cooling water, the coolant warning light came on and the system would no longer go through the start up procedure.Another hand piece was retrieved and attached.At the point the system worked satisfactorily.There was no patient injury reported.Additional information received on 28jul2020 indicated that the malfunction was discovered after the start of the surgery.The patient was prepped for surgery and incision was made.There was a delay for more than an hour.Patient was bleeding and they had to abort the use of the device and switched to using the stryker sonapet.Patient's condition was stable after the procedure.

• 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 ; 1000 campus drive; princeton, NJ 08536 ; 6099362319
• MDR Report Key: 10406747
• MDR Text Key: 207736991
• Report Number: 3006697299-2020-00093
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K141668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C2600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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