MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 23KHZ STRAIGHT HANDPIECE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C2600

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on 03mar2016.The investigation included: methods: evaluation of actual device; review of device history records; review of complaint history.Results: evaluation of device: during investigation it was observed that the cable was defective (hole).No non-conformance reports were raised during the manufacturing process for this handpiece.All results of the functionality tests were recorded as within specification prior to the handpiece been released.A minimum of 12 months review of cusa excel handpieces part number c2600 was completed using the following key words ¿tubing or cord failure¿ and root cause ¿ defective cable¿ in the search criteria.The review encompassed pr from dates 29-feb-2015 to 02-mar-2016.The analysis of the complaint investigations and root cause reports has concluded this complaint is the (b)(4) identified cusa excel c2600 handpiece complaint for the reported failure with the root cause identified as ¿defective cable¿ resulting in the tubing/ cord failure.The failure analysis investigation has concluded the root cause of the cusa excel handpiece not correctly repaired due to a defective cable.

Event Description

The device has been repaired on 03feb2016.The customer returned the device because there was a hole in the tube.The product was not in contact with patient.There was no injury.The event did not lead to an increase of surgery time.

• Brand Name: CUSA EXCEL 23KHZ 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: 5514978
• MDR Text Key: 40834191
• Report Number: 3006697299-2016-00110
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C2600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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