MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR CUSA EXCEL 23KHZ CEM NOSECONE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C6623

Device Problem Failure to Shut Off (2939)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2015

Event Type  malfunction  

Event Description

The coagulation function was activated from the start without pressing the coag button and could not be turned off.It was replaced with a new unit immediately without any injury to the pt.Additional info has been requested and the following was received from the distributor on (b)(6) 2015.The incident occurred on (b)(6) 2015 when the doctor tried to use the handpiece for the first time during the surgery (type of surgery unk) on a female pt.The doctor noticed that it was activated when he tried to use the handpiece.It was unk when the coag was activated and what the setting was.There was just a few minutes delay in surgery to exchange the nosecone.There was no pt adverse consequence as a result of the surgical delay.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported info.

Manufacturer Narrative

Integra has completed their internal investigation on 11/04/2015.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: complaint confirmed: the nosecone failed the conductivity test- the ohm reading did not drop when the switch was pressed.The nosecone also failed the circuit insulation property test, reading 0 mega ohms.The nosecone (p/n 72903913, "cusa nosecone 23khz") product is manufactured by (b)(4) supplier, known previously as omni plastics, inc.(also fpe life sciences), and shipped to integra (b)(4) for packaging and sterilization process.As part of the release process of the fg lot #1144722, the related documentation was audited by product release department.The fg lot was released for distribution purpose in compliance with the product specifications and quality system requirements of integra.For the complaints occurrence rate calculation, applicable to this investigation, the timeframe was defined since the new ifu implementation date of january 17, 2014 - june 5, 2015.Within this period, (b)(4) complaints have been reported regarding the reported condition in cusa nosecone; approximately (b)(4) units of cusa nosecones products family have been released for distribution.This results in a complaint occurrence rate of approximately (b)(4).Conclusion: root cause for the failure mode reported in this incident was the electro-migration of tin (metal used as a solder) across the pcb (printed circuit board) switch contacts.

• Brand Name: CUSA EXCEL 23KHZ CEM NOSECONE
• Type of Device: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4875607
• MDR Text Key: 6260604
• Report Number: 3006697299-2015-00093
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K981262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C6623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1