MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC; INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE

Model Number	72-00322-0
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 11mar2022 northgate technologies, inc was made aware of the alleged event.Based on the information provided through 18mar2022, there was no adverse event to the patient, and the adverse event experienced by the technician was minor and did not require any additional therapy or treatment to resolve.Capa (b)(4) was initiated to investigate the malfunction of the probe.The device history record for bsc15010 from (b)(6) 2021 (mo 15010) was reviewed and the lot passed all testing.Nothing out of the ordinary was noted.The probe was returned for evaluation on 17mar2022.Based on the initial evaluation, the probe did not fire at the tip and has a short at the connector as the complainant described.There was an audible sound when the probe was fired from the connector.Also the center conductor was noted to be protruding and tip was intact.It is currently unknown how the short at the connector was able to circumvent the insulation at that location.The probe is designed so that the two wires that carry the electric charge from the connector to the tip are insulated by the polyimide material and for half the probe the polyimide is reinforced by the "clear" kynar material from the connector end.The investigation will proceed and a follow up vigilance report will be submitted once this has been completed.
Event or Problem Description
On 11mar2022 northgate technologies, inc was made aware of an alleged event from distributor boston scientific corporation,".Initially, the probe was set to medium power, 10 shots, and when the ehl pedal was depressed, nothing happened to the stone that was lodged between the cystic duct and the bile duct.The physician requested the power be turned up to high, maximum shots, and suddenly the technician holding the probe experienced a shock to her hand that was visible (spark) and audible (loud crack) to the room.The technician claims she is experiencing residual pain, even an hour post procedure (at the time of this written complaint).They removed the probe and used another of the same.The new probe worked and the procedure was completed.The technician is okay, but she claims she has a burning pain in her hand preventing her from working.The hospital is filing an incident report and wants to know the results of our findings on the probe.".Based on additional questions asked from the manufacturer the initial reporter indicated on 18mar2022 that no additional therapy or treatment was offered to the technician and that they were "able to rest while her hand recovered.", "she said her (right) hand appeared more red than her left hand." and as of 18mar2022 "she said she is better now.".
Event or Problem Description
On 11mar2022 northgate technologies, inc was made aware of an alleged event from distributor boston scientific corporation,".Initially, the probe was set to medium power, 10 shots, and when the ehl pedal was depressed, nothing happened to the stone that was lodged between the cystic duct and the bile duct.The physician requested the power be turned up to high, maximum shots, and suddenly the technician holding the probe experienced a shock to her hand that was visible (spark) and audible (loud crack) to the room.The technician claims she is experiencing residual pain, even an hour post procedure (at the time of this written complaint).They removed the probe and used another of the same.The new probe worked and the procedure was completed.The technician is okay, but she claims she has a burning pain in her hand preventing her from working.The hospital is filing an incident report and wants to know the results of our findings on the probe.".Based on additional questions asked from the manufacturer the initial reporter indicated on 18mar2022 that no additional therapy or treatment was offered to the technician and that they were "able to rest while her hand recovered.", "she said her (right) hand appeared more red than her left hand." and as of 18mar2022 "she said she is better now.".
Additional Manufacturer Narrative
On 11mar2022 northgate technologies, inc was made aware of the alleged event.Based on the information provided through 18mar2022, there was no adverse event to the patient, and the adverse event experienced by the technician was minor and did not require any additional therapy or treatment to resolve.Capa 22019 was initiated to investigate the malfunction of the probe.The device history record for bsc15010 from january 2021 (mo 15010) was reviewed and the lot passed all testing.Nothing out of the ordinary was noted.The probe was returned for evaluation on 17mar2022.Based on the inital evaluation, the probe did not fire at the tip and has a short at the connector as the complainant described.There was an audible sound when the probe was fired from the connector.Also the center conductor was noted to be protruding and tip was intact.It is currently unknown how the short at the connector was able to circumvent the insulation at that location.The probe is designed so that the two wires that carry the electric charge from the connector to the tip are insulated by the polyimide material and for half the probe the polyimide is reinforced by the "clear" kynar material from the connector end.Investigation of the probe determined that there was a break-down in the insulation of the wire at the connector which may have contributed to an arc, or short within the connector.While the insulation of the wire appears to have been compromised, the probe has multiple layers of protection at the connector including (besides the wire insulation): polyimide tubing, kynar stiffening tubing, epoxy encapsulation, and connector boot.These other layers of protection were determined to still be intact during the evaluation.It is therefore unknown how the user experienced a shock from the breakdown in insulation.This is the first time that a complaint has been received regarding a user that has been injured by holding onto the connector.This failure mode will be trended.

• Brand Name: AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC
• Common Device Name: INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer (Section G): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer Contact: todd gatto ; 1591 scottsdale court; elgin, IL 60123 ; 2248562250
• MDR Report Key: 14056873
• Report Number: 0001450997-2022-00004
• Device Sequence Number: 11922891
• Product Code: FFK
• UDI-Device Identifier: 00817183020448
• UDI-Public: 00817183020448
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2024
• Device Model Number: 72-00322-0
• Device Catalogue Number: M00546620
• Device Lot Number: BSC15010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown