MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) SELECTOR 35KHZ NEURO HANDPIECE; N/A

Catalog Number 1523000M9

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 1 of 4 reports linked to mfg report numbers: 3006697299-2022-00095, 3006697299-2022-00096, 3006697299-2022-00097.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

The selector 35khz neuro handpiece (1523000m9) 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

The selector 35khz neuro handpiece (1523000m9) was returned for evaluation; however, this device has been discontinued and is not serviceable.The device was manufactured over 10+ years old ago and no service records have been found for same.

• Brand Name: SELECTOR 35KHZ NEURO HANDPIECE
• 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 Key: 14956593
• MDR Text Key: 295493717
• Report Number: 3006697299-2022-00094
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K021989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 1523000M9
• 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 Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/18/2022; 12/21/2022
• Supplement Dates FDA Received: 07/28/2022; 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1528020M7 24KHZ SHORT HANDPIECE (SN :(B)(6)); CUSANXR (SN:(B)(6)); CUSANXT1SERVICE MODULE (SN:(B)(6))
• Patient Age: 74 YR
• Patient Sex: Female