MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿ PLUS (5 PACK)

Catalog Number	C7415S
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report is 2 of 2 linked to mfg report number 3006697299-2025-00042: a facility reported that during the surgical procedure for transsphenoidal microadenoma resection, the specialist began using the aspirator and stated that the tip felt too hot.This was confirmed by the surgical consultant, who noted that the tip felt hot, but the handpiece was at a normal temperature.The parameters on the screen were checked and were: amplitude: 80; aspiration: 100; fluid: 3; select tissue: low.At the end of the procedure, the doctor decided to use the aspirator again, changing the amplitude to 90 and the irrigation to 2.The doctor used the aspirator for one minute and left it on the dressings.At that point, it became clear that the tip was too hot, and the entire unit was disassembled.Due to the extreme heating of the tip, dr.[redacted] indicated that the patient had suffered a dural rupture.Additionally, a burn was seen on the urology equipment cable when the handpiece was placed on the fields, indicating that the tip was quite hot.Tests were conducted with the biomedical engineer, who contacted integra's technical department to resolve the issue, which is currently underway.I also want to report that this is the second time this type of heating has occurred, so we want a thorough analysis of the case to prevent future cases from occurring and causing harm to any patient.Additional information subsequently received as follows: 1.Patient's condition: stable, no complications.2.Was the surgery successful? yes, the surgery was successful.3.Did the patient require further medical attention or surgery? no.4.There is a comment: "i also want to report that this is the second time this type of heating has occurred." was it the same handpiece or a different one? the incident occurred with the same equipment and the same handpiece.5.Was a complaint filed for the previous case? no, the first situation was not formally reported to complaints.The biomedical department tested the equipment and it worked properly, and there were no new developments.Since this is the second time, we feel it is important to report it for follow-up.
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: d4, d9, g3, g6, h2, h3, h4, h6, h11.The c7415s cusa clarity 36khz curved extended microtip¿ plus was not returned; therefore, an evaluation of the device could not be performed.However, investigation using an image provided by the customer was performed as follows: device history record (dhr) review - lot number information has been provided; therefore, the dhr was reviewed and found no anomalies.Failure analysis: according to the customer, the surgery was reportedly completed successfully and the patient reportedly had no complications or injuries, despite the initial report of a dural rupture.This is reportedly the second incident of overheating for this customer.Investigation for the alleged first overheating incident is on mfg report number 3006697299-2025-00046.Pictures were provided, appearing to show evidence of the alleged overheating and urology equipment cable damage.Therefore, the reported overheating issue is confirmed from the evidence in the pictures provided, however no further failure analysis is possible.Root cause: a root cause determination for this alleged overheating issue is not possible, as the product has not returned for evaluation.No relevant capas were discovered and no other actions have been identified relating to this issue, and no manufacturing, workmanship, or material deficiency was identified for correction as a result of this complaint investigation.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿ PLUS (5 PACK)
• Common Device Name: CUSA CLARITY
• 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: 21856737
• Report Number: 3006697299-2025-00045
• Device Sequence Number: 11939368
• Product Code: LFL
• UDI-Device Identifier: 10381780126379
• UDI-Public: 10381780126379
• Combination Product (Y/N): N
• PMA/510(K) Number: K161882
• 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): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: C7415S
• Device Lot Number: 7343144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Hispanic