MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY CONSOLE

Catalog Number C7000

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A sales representative reported on behalf of the customer that the c7000 cusa clarity console did not work due to a system error during the first product evaluation on (b)(6) 2019.The device was verified and tested by an integra engineer more than one month ago.After that test, the cusa had never been used until the product evaluation.The reported error on the console was: "1208 ib-vacuum_pressure_low".There was no patient contact or injury.The event increased surgery time to thirty (30) minutes.

Manufacturer Narrative

A field service of the device was done on (b)(6) 2019.The complaint was verified as valid.The cause was identified as the console's aspiration assembly elbow open orifice was broken.The device history record documentation was reviewed and no anomalies that could be associated with the complaint incident were observed.There is no service history for the device under evaluation.Device identifier: (b)(4).Product identifier: (b)(4).

• Brand Name: CUSA CLARITY CONSOLE
• Type of Device: CUSA CLARITY
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• MDR Report Key: 8635904
• MDR Text Key: 150850682
• Report Number: 3006697299-2019-00058
• Device Sequence Number: 1
• Product Code: LBK
• Combination Product (y/n): N
• PMA/PMN Number: K161882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C7000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1