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

Catalog Number	C2602
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This is linked to mfg report numbers: 3006697299-2024-00072, 3006697299-2024-00078, 3006697299-2024-00079.A facility reported that during a craniotomy tumor removal surgery, the surgeon was using a cusa excel 36khz straight handpiece (c2602), and it was not removing the tissue well and as efficiently as expected, so they swapped to another handpiece, and it was better but still not as well as expected.The surgeon continued using and completed the procedure with the swapped handpiece.There was no patient injury; however, there was a delay of 30 minutes as they swapped for another handpiece to complete the surgery.Additional information states that two 36khz handpieces did not work properly during the case, but that the facility will be returning all handpieces for inspection.However, since customer did not report which of the 36khz handpieces were used, mdrs are being submitted for all 4 devices being returned.
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.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h3, h11.Additional information received as follows: reason for return/complaint: >> the cavitation of the handpieces during surgeries is very sporadic.This was not the first time this had happened, and this was an ongoing issue.Age and gender of patient: >> child.What was the patient outcome: >> treatment of the patient was not up to standard.Medical intervention: >> use of another company¿s device, sonopet to complete the surgery.Surgery could not be completed otherwise.
Additional Manufacturer Narrative
The 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 evaluation was unable to conclusively verify customer information as valid: the device passed all cosmetic and functional testing and meets specification.Preventative maintenance (pm) was recommended and then performed to manufacturers specifications.Root cause: the root cause is undetermined since the reported failure was not confirmed.As a result, no corrective action is required.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: 19489090
• Report Number: 3006697299-2024-00076
• Device Sequence Number: 8544993
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2024

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): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 07/03/2024; 09/17/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 08/02/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2017
• 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
• Patient Sex: Unknown