MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 36KHZ STRAIGHT HANDPIECE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C2602

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2018

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 customer reported that a c2602 cusa excel 36khz straight handpiece was not working during a procedure.They tried using a different handpiece and it worked.Additional information received on (b)(6) 2018 indicated that the event happened on (b)(6) 2018 during a craniotomy (brain tumor) case.The device did not cavitate.The device was in contact with the patient but no injury was reported.There was a 15-minute surgery delay but there was no impact to the patient.The case was completed with another handpiece.Additional information has been requested.

Event Description

N/a.

Manufacturer Narrative

The device was returned for evaluation.The device history record (dhr) reveals no anomalies that could be associated with the complaint incident were observed.A defective coilform was verified as the cause of the complaint incident.Further additional information regarding the failure and cause was not provided.The complaint was verified as valid.

• Brand Name: CUSA EXCEL 36KHZ STRAIGHT HANDPIECE
• 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
• MDR Report Key: 8152750
• MDR Text Key: 130348073
• Report Number: 3006697299-2018-00077
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C2602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1