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

Catalog Number C2602

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A distributor reported on behalf of the customer that the c2602 cusa excel 36khz straight handpiece did not pass the amplitude test and it gave a vibration alert on (b)(6) 2020.There was also no output when they pressed the orange vibration foot pedal in run mode.They tried changing the tip but the alarm was still there.They were able to confirm the problem of the handpiece by checking another good handpiece using the same cusa console and found the cusa working.There was no patient contact or injury and no known delay in surgery.

Manufacturer Narrative

Device identifier: (b)(4).Product identifier: (b)(4).The device was not retuned for evaluation.The dhr documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.A complaint investigation (failure analysis) and determination of root cause was not possible.The complaint could not be verified due as a product sample was not returned in order to verify the complaint.Based on the customer reported failure ¿does not get pass, and gives vibration alert ¿.Its possible this complaint was as a result of transducer delamination.However, without testing it is not possible to verify.Should the product be returned for analysis the complaint will be reopened and evaluation will be completed.

Event Description

N/a.

Manufacturer Narrative

Cusa excel 36khz straight handpiece (c2602) was returned for evaluation.The reported complaint was confirmed.Unit does not pass tests and gives vibration alert.Device did not meet specification during testing.The handpiece issue was due to transducer delamination caused by transducer braze degrading in the field.The solution was identified as using an alternative braze filler alloy which does not contain zinc.A trial was completed which confirmed that the use of a trial alternative braze alloy.The trial confirmed that the change does not affect the handpiece function.Corrective action was implemented in april 2021.This device was manufactured prior to corrective action.No post corrective action failures have been identified.

• Brand Name: CUSA 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
• MDR Report Key: 10349575
• MDR Text Key: 203648760
• Report Number: 3006697299-2020-00085
• 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: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

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: C2602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Manufacturer Received: 03/29/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 08/26/2020; 07/16/2021
• Supplement Dates FDA Received: 09/21/2020; 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1