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

Catalog Number C2602

Device Problems Failure to Power Up (1476); Device Inoperable (1663)

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

Event Date 09/28/2015

Event Type  malfunction  

Event Description

It was initially reported that the handpiece does not work.Additional information was received on 23 oct 2015 with the following: the issue was detected during surgery while in use on a (b)(6) female patient on (b)(6) 2015.The surgery was delayed approximately 1 hour.There was no consequence for the patient / no patient injury.Additional information has been requested.

Manufacturer Narrative

Integra completed its internal investigation 11/19/2015.The investigation included: method: -dhr review, - review of complaint management database for similar complaints.-visual examination.Results: date of manufacture: oct-2014.Device history review for cusa excel handpiece c2602 serial number (b)(4) indicate no non-conformance reports were raised during the manufacturing process for this handpiece.All results of the functionality test were recorded as within specification and final release checks were performed satisfactory prior to the handpiece been released.No service history for this cusa excel handpiece, serial number (b)(4).A minimum of 12 months review of cusa excel handpieces part number c2602 was completed using the following key words ¿handpiece not working¿ and root cause ¿ could not duplicate¿ in the search criteria.This review encompassed dates 14-oct-2014 to 28-oct-2015.This is the 9th identified cusa excel c2602 handpiece complaint for the reported failure with the root cause identified as ¿could not be duplicated¿ resulting in handpiece not working.Reported failure was not confirmed; during investigation it was observed that the handpiece passed all specification tests.Conclusion: the failure analysis investigation has concluded the root cause of the handpiece does not work was not duplicated, thereby no fault found.

• 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
• 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: 5205936
• MDR Text Key: 30710814
• Report Number: 3006697299-2015-00159
• 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: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

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: C2602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 11/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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
• Patient Age: 33 YR