MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL W/ CONSOLE 110V AC WITH FOOTSWITCH; ULTRASONIC SURGICAL PRODUCTS

Catalog Number CUSAEXCEL2

Device Problems No Device Output (1435); Failure to Power Up (1476)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Cusa excel2 was not at full power when the hand piece was connected.The or tried 3 tips, 3 hand pieces and 2 sets of tubing.Once connected, they tested the machine and primed.Doctor had the nurse set the cusa settings at full power.Doctor pressed on the pedal and there was no power.There was no patient contact or injury.There was a 1 hour delay in surgery.Additional information has been requested.

Manufacturer Narrative

Investigation was completed on 5/19/2017.Dhr was reviewed and no anomalies that could be associated with the complaint incident were observed.Date of manufacture: 2012 ¿ jun.Service history review: the service history was reviewed and no anomalies that could be associated with the complaint incident were observed, a review of cusa excel complaints was completed using the following key words ¿ultrasonic¿ in the search criteria.The review was specific to 202750281 boards.The review encompassed dates 18-may-2016 to 18-may-2017.Three complaints were applicable to the complaint incident.The review of the complaints identified in the search criteria verified no anomalies that could be associated with the complaints were observed.Additionally, the review verified this is the single complaint occurrence for the device under evaluation.New ultrasonic board 72903374 was validated and released in dec 14.The complaints identified in the complaint review were not associated with the new 72903374 board.Rate of occurrence: (b)(4).Conclusion: an integra service engineer visited the facility where the complaint evaluation was performed.The complaint was verified as valid, the cause was identified as a defective 202750281 ultrasonic board.

• Brand Name: CUSA EXCEL W/ CONSOLE 110V 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6519915
• MDR Text Key: 73916644
• Report Number: 3006697299-2017-00064
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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