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 07/28/2021

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 report is for the 1st of 3 procedures linked to mfg report numbers 3006697299-2021-00031 and 3006697299-2021-00032: a facility reported that during three tumor removal procedures, the surgeon experienced low amplitude issues with the cusa excel w/ console (cusaexcel9), and stated that the device did not work properly in fragmenting.The procedure was completed with 'tumor removed with bipolar'; however, there was significant increased surgery time of 30 minutes.No patient injury was alleged.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h10 additional information and clarification received from customer as follows: only two events occurred on 28 july, 2021, and not three as initially reported.Only one surgery, one patient impacted on 28 july and two consoles failed with low amplitude during the same surgery, not three as initially indicated.First console was set up and failed, then accordingly, another console was taken and also failed.

Manufacturer Narrative

Even though information was reported in follow mdr #1 that this cusa excel w/ console did not fail, the customer returned it for evaluation, the findings are as follows: device history record (dhr) ¿ the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - evaluation showed that the device tested at low amplitudes, no drops seen.Root cause - the root cause was confirmed as no fault found.The device passed all testing and meets specification.

• 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: 12334068
• MDR Text Key: 267050318
• Report Number: 3006697299-2021-00030
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• 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
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2017
• 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