MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA EXCEL 23KHZ LAPAROSCOPIC TIP ELT; ULTRASONIC SURGICAL PRODUCTS

Model Number	C4604ELT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during use of the cusa excel 23khz laparoscopic tip elt (c4604elt), the alarm rang during handpiece testing.The alarm message requested to change the handpiece; the medical staff changed the handpiece, but the alarm rang again.They changed the generator and the alarm rang again.They then changed the unit; there was no alarm, and the cusa system functioned as expected.There was no consequence for the patient during surgery; however, there was increase of surgery time of 30-40 minutes.The adult patient is doing well.
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
The cusa excel 23khz laparoscopic tip (c4604elt) was returned for evaluation: failure analysis - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint.The returned tip was tested twice, and it passed with full amplitude and no errors both times.The error could have been caused by a wide variety of possible factors, however without having been present at the time it occurred, without any other visual indications such as damage present, and without being able to recreate the issue, it is not possible to determine the root cause with certainty.Root cause - the complaint is unconfirmed from the investigation.The most probable root cause is generally use error.The cusa excel user guide includes a description of possible alarms (errors), guidelines on how to resolve an alarm, and general troubleshooting procedures.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: CUSA EXCEL 23KHZ LAPAROSCOPIC TIP ELT
• 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: 16322575
• Report Number: 3006697299-2023-00015
• Device Sequence Number: 12923138
• Product Code: LFL
• UDI-Device Identifier: 10381780025931
• UDI-Public: 10381780025931
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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 Model Number: C4604ELT
• Device Catalogue Number: C4604ELT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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