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Model Number 72-00275-0
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
During preventative maintenance of the device at northgate technologies, inc; it was noted in service evaluation the insulated wire from the high voltage transformer was disconnected from the high voltage printed circuit board (hv pcb). There was no evidence of arcing within the unit (metal housing) or that the unit was fired with the disconnected "broken" wire from the high voltage board. It is currently unknown if this damage was present in the field or occurred in transit. This report is being filed as a malfunction because the disconnection of the wire from the transformer to the hv pcb constitutes an increased risk of potential shock if the disconnected wire were to come into contact with the metal housing. The device was investigated under capa (b)(4). There are no burn marks found inside the cover which supports that the unit has not been discharged after the high voltage wire broke from the high voltage board. It is unclear at this time how the hv wire became disconnected from the hv pcb. A possible root cause could be that this occurred during a cover removal and re-installation process of the unit at the user facility and the insulated wire from the high voltage transformer to the pcb was either accidentally pulled or yanked. Warnings have been provided in the operator's manual that "the unit should not be opened except by a qualified service person. Tampering by unqualified persons can damage the unit and void the warranty". The operators manual indicates the dielectric and leakage testing has to be performed annually on devices. This device would fail that testing with the wire disconnected. The device history record for 22963edc from may of 2019 ((b)(4)) was reviewed and the device passed all testing. Nothing out of the ordinary was noted. The device has not been returned to nti for repair / evaluation previously. There have been no other complaints reported to nti for this device. This is the third instance of a wire on the secondary side of the hv output transformer breaking and compromising the isolation protection. The (b)(4) risk analysis was reviewed. Line item 7. 3. 5 discuss accidental mechanical damage with a potential hazard of a delay in procedure or possibly injury. In the case of this complaint the most likely occurrence would be 7. 3. 5 (a) a delay in the surgical procedure. This has an occurrence rate of a 2 (remote, very unlikely to happen) and a severity of a 1 (negligible, minor discomfort or pain, no permanent impairment), which corresponded to an acceptable risk with no further mitigation needed. Based on the nature of the failure observed given that the hv wire was disconnected, there is an increased risk of shock (indicated below). The (b)(4) section 7. 1. 1(a) addresses, "electricity - possible shock to patient and/or user due to electric shock" with the possible hazard identified as "break down of insulation on internal generator wires could cause electric shock". The mitigation is that the device was evaluated and passed iec 60601-1 safety testing. The severity is identified as a 5 (potential death) with a likelihood of severity of a 1 (incredible). The risk of death, or serious injury is considered less than remote. A clinical evaluation was performed per (b)(4) which proved the benefits of lithotripsy outweigh the risks. If further information were to become available, a follow-up report would be submitted.
Event Description
During the preventative maintenance of the device at northgate technologies, inc, it was identified in service evaluation that the insulated wire from the high voltage transformer was disconnected (wire broken) from the high voltage pcb within the unit.
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Manufacturer (Section D)
1591 scottsdale court
elgin IL 60123
Manufacturer (Section G)
1591 scottsdale court
elgin IL 60123
Manufacturer Contact
todd gatto
1591 scottsdale court
elgin, IL 60123
MDR Report Key12961894
MDR Text Key285241283
Report Number0001450997-2021-00010
Device Sequence Number1
Product Code FFK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Remedial Action Repair
Type of Report Initial
Report Date 11/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number72-00275-0
Device Catalogue NumberM005466800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2021
Date Manufacturer Received11/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse