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

Catalog Number C7000

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not yet received by 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 biomed technician reported that the c7000 cusa clarity console showed an error message "1219 ib_aspiration_rpm, when the nurse changed suction "constant" for "on demand".The surgery was almost done by the surgeon and the cusa clarity was not used after the incident and until the end of the surgery case on (b)(6) 2020.There was no patient injury or delay in surgery.The cusa clarity was considered "not operational".

Manufacturer Narrative

Unique device identifier: (b)(6).Device history record (dhr) - the dhr documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.A complaint investigation (failure analysis) and determination of root cause is not possible.The complaint could not be verified due to product sample not being returned after 3 documented requests.The reported failure, ¿not operational¿ and "error message 1219 ib_aspiration rpm", is possibly the result of a defective suction pump or possible suction elbow issue.However, without physical testing of device, it is not possible to verify.Should the product be returned for analysis, the complaint will be reopened and evaluation will be completed.

Event Description

N/a.

• 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: 10514008
• MDR Text Key: 211688407
• Report Number: 3006697299-2020-00101
• Device Sequence Number: 1
• Product Code: LFL
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• 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?: No
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1