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

Model Number	C4613S
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cusa excel 36khz standardtip straight (c4613s) was not returned for evaluation as per customer, the device was blood contaminated; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.Without the return of the product for an alleged functional issue such as this, the complaint is unable to be confirmed, and root cause determination is not possible.No further investigation required based on the acceptability of risk.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
This is 3 of 4 reports linked to mfg report numbers: 3006697299-2022-00021, 3006697299-2022-00022, and 3006697299-2022-00024.A facility reported that the amplitude could not go up during fragmentation.They changed to a new tip and consumables.Cusa excel 36khz standardtip straight (c4613s) was involved, and surgical delay of 30-40 minutes was reported.There was no adverse patient consequence.

• Brand Name: CUSA EXCEL 36KHZ STANDARDTIP STRAIGHT
• 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 ; 6099362319
• MDR Report Key: 13599642
• Report Number: 3006697299-2022-00023
• Device Sequence Number: 1930667
• Product Code: LFL
• UDI-Device Identifier: 10381780026044
• UDI-Public: 10381780026044
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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 Expiration Date: 02/29/2024
• Device Model Number: C4613S
• Device Catalogue Number: C4613S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 02/25/2022
• Date Device Manufactured: 02/16/2021
• 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