MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LIMITED 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 Type  Injury  

Event Description

This is the first of two reports (same distributor, same product id, different serial numbers, different patients).It was reported that the handpiece did not function correctly; found during a field service by an integra tech in apr2015.Initially, the distributor identified the console as being responsible for the incident.The dysfunction identified the console as being responsible for the incident.The dysfunction was detected during the procedure.The date of the event was either at the end of (b)(6) 2014 or into the first days of (b)(6) 2014.There was no patient injury reported.The cusa did not work and the doctor did not use it.A 36 khz straight tip was used.The dysfunction increased surgical time to more than one hour.The patient was already under anesthesia when the event occurred.Brain tumor surgery was performed on a (b)(6) female patient.In april 2015, the tech visited the distributor to repair the console.The console functioned correctly but not the handpiece.

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 07/03/2015.Results: reported failure was confirmed, during investigation it was observed that the transducer has low power.As part of the repair, new transducer sn (b)(4) was replaced, as well as handpiece housing and the o-rings were replaced.The handpiece was calibrated and tested to specification prior been returned to customer.Dhr review was completed for cusa excel handpiece serial number (b)(4), work order (b)(4), to identify any recorded anomalies that could be associated to the complaint incident date of manufacture december 2013.No non-conformance reports were raised during the manufacturing process for this handpiece.All results of the functionality tests were recorded as within specification and final release checks were performed satisfactory prior to the handpiece been released.The reviewed service history documentation for cusa excel handpiece serial number (b)(4) has identified no issues related to complaint incident.The dhr review has been deemed satisfactory.A minimum of 12 months review was completed in trackwise using the following key words "hp not working" in the search criteria.The key word search review contained all and/or part of the key words to complete a comprehensive trend review capa has been instigated by engineering to investigate and correct failures encountered with c2602 devices related to transducer issues.Conclusion: the failure analysis investigation has concluded the root cause of the handpiece not function correctly was due to a faulty transducer which was out of specifications.

• Brand Name: CUSA EXCEL 36KHZ STRAIGHT HANDPIECE
• Type of Device: ULTRASONIC SURGICAL PRODUCTS.
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LIMITED; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: rowena bunuan ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4764840
• MDR Text Key: 5792809
• Report Number: 3006697299-2015-00064
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: AL
• PMA/PMN Number: K141674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C2602
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2015
• Initial Date FDA Received: 05/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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
• Treatment: 36 KHZ STRAIGHT TIP.
• Patient Outcome(s): Other