MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL + ULTRASONIC TISSUE ALBATION SYSTEM; N/A

Catalog Number CUSAEXCEL2

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that the vibration and system warning lamps of the cusaexcel2 cusa excel + ultrasonic tissue albation sys were lit when the chip test was performed during a laparoscopic surgery on (b)(6) 2020.No patient injury was reported.There was a delay in surgery for over 30 minutes due to the product problem with no adverse consequence to the patient.Patient information was not available and no further information was provided by the facility.

Manufacturer Narrative

The device was not returned for evaluation therefore the failure analysis and determination of root cause was not possible.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 not confirmed.

• Brand Name: CUSA EXCEL + ULTRASONIC TISSUE ALBATION SYSTEM
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• MDR Report Key: 10280873
• MDR Text Key: 202940472
• Report Number: 3006697299-2020-00072
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CUSAEXCEL2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1