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

Catalog Number	C2602
Medical Device Problem Codes	Smoking (1585); Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A distributor reported that during "removal of abdominal abscess" procedure, the cusa excel 36khz straight handpiece (c2602) failed.There was no patient injury.Additional information was subsequently received indicating the following: "after 2 hours of using the cusa excel ((b)(4)) without intervals, it stopped and turned on all the lights and it took an average of 3 minutes to return to operation, i redid the initial tests, the doctor started using it again but reported that he smelled burning, but i didn't smell any burning smell and neither did anyone else in the room.He took another 5-minute break and was able to use it until the end of the surgery.Power drop during operation, confirmed in the technical assistance test.¿.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.Additional information was received indicating the following: can we clarify if these constitute a delay in surgery for 8 mins? yes.Investigation: the cusa excel 36khz straight handpiece (c2602) was returned for evaluation: device history record (dhr) - the dhr documentation was reviewed and no anomalies during the manufacture or packaging that could be associated with the complaint incident was observed.Failure analysis - the investigation of the unit confirmed the complaint: testing of the returned handpiece found that it failed the amplitude test, with an amplitude error tip alarm occurring.Root cause - based on the testing performed, the most likely root cause is transducer delamination.Internal corrective action was implemented in march 2023 to address this issue; however, this handpiece was manufactured prior to corrective action implementation.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: CUSA EXCEL 36KHZ STRAIGHT HANDPIECE
• Common Device Name: 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: 19182571
• Report Number: 3006697299-2024-00043
• Device Sequence Number: 7281017
• Product Code: LFL
• UDI-Device Identifier: 10381780039433
• UDI-Public: 10381780039433
• Combination Product (Y/N): N
• PMA/510(K) Number: K141674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: C2602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CUSAEXCEL8 CONSOLE 220V AC WITH FOOTSWITCH
• Patient Sex: Unknown