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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CUSA NXT SERVICE MODULE (115V); N/A

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INTEGRA LIFESCIENCES(IRELAND) CUSA NXT SERVICE MODULE (115V); N/A Back to Search Results
Catalog Number CUSANXT1
Device Problem Failure to Cut (2587)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/06/2022
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
This is 4 of 4 reports linked to mfg.Report numbers: 3006697299-2022-00094, 3006697299-2022-00095, 3006697299-2022-00096.Description of surgical procedure: "a surgical procedure is started in a 74-year-old female patient, who will undergo a resection of a meningioma in the thoracolumbar spine, the patient is placed in the prone position, a specialist proceeds to demarcate the incision under the guidance of fluoroscopic images, identifying the thoracic spine t9- t10, where it lodges in a meningioma, a surgical approach is performed by planes, distraction of vertebral segments is performed with pedicle screws, fibrous tumor lodged in the vertebrae continues to be resected, it continues to reach the interdiscal spaces of the column, where the resection of the tumor, which the surgeon decides to continue with our cusa nxt ultrasonic aspirator, to remove the tumor that is lodged near the dura mater, prior to this, the installation of the equipment is carried out, initially the piece is assembled 1528020m7 with its respective key, adjusting them properly, then the assembly of the pipes is carried out s in the piece of hand, then continue adjusting the pipe in the equipment, connect the suction filter of the pipe set, in the suction control port, then we continue the installation of the pipe set in the irrigation pump, from the iv bag of saline solution , in the upper central part of the front section of the service module we continue the placement of the filter for the suction pipe, which leads internally in the vacuum pump, we use a waste collection canister, adjusting each connection port of vacuum of the corresponding equipment, continue placing the connection port of the handpiece, in the corresponding place in the equipment, continue placing the pedal of the equipment in the back, after completing the previous steps, proceed to turn on the equipment , initially we turn on the service module, once this is done, we continue to turn on the console, we wait the necessary time for the system to load ma, this shows us the home screen a red line, and moving waves on the screen, which do not affect the touch, it can be manipulated.We continue priming the handpiece, we wait for the time required by the system to perform the irrigation through the pipes, this confirms that the piece is ready to be used, we proceed to carry out the pertinent tests of operation of the piece , and pressing the ignition pedal, it is possible to hear the start of the equipment, and the suction, the specialist is asked the percentage of ultrasound, aspiration, and irrigation, to be established on the screen of the equipment, prepared this, wait for that the specialist asks us for the handpiece, we continue the introduction of the piece in the cavity to perform the tumor resection and this does not destroy the patient's tumor, the speed of the ultrasound is increased 40-50-60-70-80-90% until reaching 100% to verify the operation of the piece, and it continues the same, the piece fails to to fragment the tumor tissue, the piece is washed, the cleaning guide is inserted through the tip of the piece, not having achieved its functioning, we remove the piece and proceeds to assemble the part 1523000m9 with the same steps as the assembly of the handpieces, the priming is carried out, we continue with the pressure on the pedal to verify the operation of the part and it continues without working, we cannot fragment the patient's tumor, the use of the equipment is not achieved.I carry out tests in a container with saline solution and the piece irrigates and sucks, but the movement of ultrasound in the water is not evident.The doctor expresses his disagreement and the risks of not having the proper functioning of of this equipment." surgery was delayed for 30 minutes with no patient injury reported.
 
Manufacturer Narrative
Cusa nxt service module (115v) (cusanxt1)was not returned for evaluation after three good faith efforts (gfes) were made; therefore, an evaluation of the device could not be performed.As a result, a complaint investigation (failure analysis) and determination of root cause is not possible.Based on the customer reported failure ¿ fails to fragment tumor¿, it is possible this complaint was as a result of a power issue resulting in insufficient vibration to fragment tumor.However, without testing, it is not possible to verify.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 Description
N/a.
 
Event Description
N/a.
 
Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h10.Cusa nxt service module (115v) (cusanxt1) was returned for evaluation; however, this device has been discontinued and is not serviceable.The device was manufactured in 2013, and review of service history confirmed no services completed.The dhr documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
 
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Brand Name
CUSA NXT SERVICE MODULE (115V)
Type of Device
N/A
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 Key14956563
MDR Text Key304523070
Report Number3006697299-2022-00097
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
PMA/PMN Number
K081459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 03/10/2023
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
Device Operator Health Professional
Device Catalogue NumberCUSANXT1
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/17/2022
Initial Date FDA Received07/08/2022
Supplement Dates Manufacturer Received07/18/2022
03/02/2023
Supplement Dates FDA Received07/28/2022
03/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
1523000M9 SELECTOR 35KHZ HANDPIECE (SN: (B)(6)); 1528020M7 24KHZ SHORT HANDPIECE (SN: (B)(6)); CUSANXR (SN: (B)(6))
Patient Age74 YR
Patient SexFemale
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