MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) EXCEL 36KHZ STRAIGHT HANDPIECE; ULTRASONIC SURGICAL PRODUCTS

Catalog Number C2602

Device Problems Device Alarm System (1012); Break (1069); Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2017

Event Type  malfunction  

Event Description

The customer had first case with this handpiece, and the handpiece did not work.At the beginning, when testing the handpiece, the vibration alarm went on and the handpiece didn't work correctly (it did not vibrate correctly).It was checked again after the case was finished and it produced the same alarm.When connecting a different handpiece to the console, it worked fine so the problem could not be the cusa console.The patient was not directly impacted by this failure.The beginning of operation was slightly delayed (15 minutes) due to this failure.There were no consequences due to this delay.The patient was already under anaesthesia when the failure occurred.Type of surgery was for metastasis after breast cancer, suboccipital right.

Manufacturer Narrative

Integra has completed their internal investigation on 03/10/2017.The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history.Results: reported failure was confirmed; during investigation it was observed that the handpiece had low power due to faulty transducer; as part of the repair, the following parts were replaced: transducer (new j15172ie) and o-rings.Handpiece was not opened.Handpiece was calibrated and functionally tested within specification prior been returned to customer.The complaint report can be closed as the reported incident was verified and duplicated.The dhr for cusa excel handpiece c2602 serial number (b)(4); work order 230975 manufactured in (b)(4) and reworked in (b)(4) under work order (b)(4), transducer serial number (b)(4), coil form traceable reference (b)(4), was reviewed and no anomalies that could be associated with the complaint were observed.Date of manufacture: sep-2014.No service history for cusa excel handpiece c2602 serial number (b)(4)¿ this is the 1st time that the handpiece will be returned for service.The dhr review has been deemed satisfactory.Rate of occurrence: the quantity of 51 x complaints over the 12-month period with the key words identified in the complaint review can therefore be calculated as 0.046% of procedures.Conclusion: product was returned and the evaluation verified the complaint incident as valid.Root cause determined; cause of the handpiece failure was due to faulty transducer serial number (b)(4).No new corrective action / preventative action is deemed required based on the risk management acceptability review and no adverse trend statistically identified.No further action is required.Future complaints will be continued to be monitored and trended.

• Brand Name: EXCEL 36KHZ 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: 6349939
• MDR Text Key: 68366941
• Report Number: 3006697299-2017-00031
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K14674
• 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: 01/30/2017

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: Health Professional
• Device Catalogue Number: C2602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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: CUSA CONSOLE
• Patient Age: 72 YR