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

Catalog Number C6636

Device Problems Loose or Intermittent Connection (1371); Product Quality Problem (1506); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2016

Event Type  malfunction  

Event Description

This is the first of two reports (same reporter, same product, similar issue).Linked to mfg.Report number: 3006697299-2016-00127.At the incoming inspection of goods by the distributor, the white band was found to be coming loose inside the unopened packages.Foreign material was also found inside the packages.Quantity of 3 packages were reported.There was no patient involvement.

Manufacturer Narrative

Integra has completed their internal investigation on 08/09/2016.The investigation included: methods: evaluation of actual device; review of device history records; review of complaint history.Results: evaluation of device: three samples of lot 1153753 were returned for evaluation.No particle was found in any of the three sealed trays sent by the customer; therefore, could not confirm the failure; regarding the opened bands two (2) of the three (3) were opened, thus confirming the opened bands failure.According to the dhr review, no anomalies were reported during the packaging process of these lots that could be related to any of the two (2) the reported condition.Nonconformance, scar, and capa reports regarding cusa nosecone products were reviewed.No associated ncr, scar and/or capa were found to be related to these failures.Review of product's complaint history from april 2014 - april 2016 (foreign material): no similar complaints related to ¿foreign material¿ have been reported for the above reported fg lots.After reviewing the complaint system from april 2014 to april 2016, seven (7) complaints related to ¿foreign material¿ (including the two being investigated) have been reported in the cusa nosecone family at integra lifesciences (b)(4) facility.(b)(4).Review of product's complaint history from april 2014 - april 2016 (loose bands): no similar complaints related to ¿the white band was coming loose inside the unopened package¿ have been reported for the above reported fg lots.After reviewing the complaint system from april 2014 to april 2016, eleven (11) complaints related to ¿the white band was coming loose inside the unopened package¿ (including the ones being investigated) have been reported in the cusa nosecone family at integra lifesciences (b)(4) facility.(b)(4).Foreign material: since foreign matter was not confirmed, no root cause was possible at this point.Loose bands: self-stick paper band (p/n 232600027) is purchased from an external supplier ((b)(4)).At the moment it is unknown if the events could be related to the self-adhesive paper.The root cause for this event is undetermined; capa was issued on 05/19/16 in order to address the increase in confirmed incidents related to cusa manifold tubing family and cusa nosecone family reporting the condition ¿the white band coming loose¿.

• Brand Name: CUSA EXCEL 36KHZ CEM NOSECONE
• 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: 5659580
• MDR Text Key: 46584421
• Report Number: 3006697299-2016-00126
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2016

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: Other
• Device Catalogue Number: C6636
• Device Lot Number: 0000001153753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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