MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LIMITED CUSA EXCEL 23KHZ CEM NOSECONE; ULTRASONIS SURGICAL PRODUCTS

Catalog Number C6623

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 09/04/2014

Event Type  Injury  

Event Description

During a laparoscopic hepatectomy, the activation did not stop.At the time, the handpiece was placed on the pt's body so the pt suffered a burn.The distributor tested the nosecone several times but could not reproduce the symptom.Add'l info was requested and on (b)(6) 2014 and (b)(6) 2014, the following was provided by the distributor: during a laparoscopic hepatectomy, the doctor once took out the cusa handpiece from the cannula and placed it on top of the (b)(6) male pt's stomach accidentally.The doctor once again inserted the cusa handpiece to the cannula, and saw output occuring even through he was not pressing on the cem nosecone button.The cut/coag settings were unk.The doctor checked the pt's stomach (where he placed the handpiece) and found a second degree burn had occurred.The incident occurred after 2 to 3 hours when surgery had started, the burn was treated by applying ointment.The nosecone was replaced with a new one and surgery was continued.There was no surgery delay.At the time, the pt was still in the hosp.

Manufacturer Narrative

To date, the device involved in the reported incident has been received for eval.An investigation has been initiated based upon the reported info.

• Brand Name: CUSA EXCEL 23KHZ CEM NOSECONE
• Type of Device: ULTRASONIS 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: 4144019
• MDR Text Key: 4930056
• Report Number: 3006697299-2014-00104
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K981262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2014

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: C6623
• Device Lot Number: 1140417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2014
• Initial Date FDA Received: 10/03/2014
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR