MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. CUSA EXCEL 23KHZ TUBING SET; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C3600

Device Problems Fluid/Blood Leak (1250); Material Perforation (2205)

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

Event Date 04/17/2017

Event Type  malfunction  

Event Description

The machine was leaking fluid from the bottom of face plate.They unlatched the irrigation pump to check the irrigation tubing.There was a slice in the irrigation tubing.The tubing was replaced.The device was used on the patient but there was no patient injury.There was no delay in surgery.Additional information has been requested.

Manufacturer Narrative

Investigation completed 6/05/17.Method: -device history review, -trend analysis, -failure analysis.Device history record (dhr) of manufacturing finished good lot 1163523 was reviewed.According to the dhr review, no anomalies were reported during the process of this lot that could be related to the reported condition.No similar complaints related to ¿slice in the tubing pump¿ have been reported for this fg lot 1163523.After reviewing the complaint system from april 2015 to april 2017, two (2) complaints (including the one being investigated) related to the reported condition has been reported in cusa manifold tubing pump family.At this moment there is no trending observed.(b)(4).One (1) unit from catalog c3600, cusa excel 23 khz tubing set corresponding to fg lot # 1163523 was received for evaluation.The returned unit was not received in the original package.The complaint states ¿there was a slice in the irrigation tubing¿ but the visual evaluation of the device did not find a slice in the paratubing.The visual evaluation identified the tubing pump, p/n 249101639, as the component with the slit and not the paratubing.Also, it was observed a slanted line with a black color inside the slit.This black mark is indicative that it was exposed to a foreign external object with black appearance that caused the black mark in the unit.Conclusion: the condition described was confirmed with the evaluation of the returned unit but not in the irrigation tubing, it was confirmed in the tubing pump, since it was observed a slice in the component.The irrigation tubing (paratubing) was verified and no slice was observed on it.The manufacturing personnel performed a 100% visual inspection of the manifold tubing assembly and qa personnel inspect visually the manifold tubing assembly, searching for holes, tears in the tubing, defective, damaged components or product.No reject was reported as result of these operations according to the dhr review of fg lot 1163523.Since the returned unit had a black mark in the slit, it is determined that the possible root cause is related to the handling of the tubing pump by the user.No assignable causes that could be associated to the manufacturing process were determined based on the review of the dhr, capa's and ncr's history.In addition, process controls are in place to detect the reported condition.

• Brand Name: CUSA EXCEL 23KHZ TUBING SET
• Type of Device: ULTRASONIC SURGICAL PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; 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: 6537343
• MDR Text Key: 74421631
• Report Number: 3006697299-2017-00067
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C3600
• Device Lot Number: 0000001163523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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