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 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

Product was not returned for evaluation.The dhr documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.The reported complaint was not confirmed.An investigation for cause was unable to be performed.Udi: (b)(4).Linked to mfg report no.: 3006697299-2019-00149 3006697299-2019-00150; 3006697299-2019-00152.

Event Description

This is 3 of 4 reports.A customer reported that they had an inspection of the c2602 cusa excel 36khz straight handpiece.They switched on the unit and completed the wait period but when they pressed the amplitude test, it did not get pass and gave vibration alert.They pressed the orange vibration foot pedal in run mode but there was no output noted and still gave them vibration alert.The customer tried to check on a new handpiece using the same cusa console and found that it was working with no problem.Additional information received on 30nov2019 indicated that the device was not in contact with the patient and no injury was reported.

Event Description

N/a.

Manufacturer Narrative

The cusa excel 36khz straight handpiece (c2602) was returned for evaluation.However, a complaint investigation (failure analysis) and determination of root cause is not possible.The complaint could not be verified.Based on the customer reported failure ¿oob failure fragmentation error¿, it is possible this complaint was as a result of transducer delamination.However, without testing it is not possible to verify.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 10280610
• MDR Text Key: 202622875
• Report Number: 3006697299-2019-00151
• 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: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• 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