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

Model Number	72-00322-0
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Northgate technologies received notification from a distributor on march 02, 2021 of the alleged event.There was no adverse impact to the patient involved in the procedure other than a minor delay to switch out the probe that malfunctioned with another probe.Northgate attempted to obtain further information about the severity of the injury to the nurse, use of the device, and to request the device be sent in for evaluation.Capa (b)(4) was initiated to investigate the alleged event.On 3/23/2021, nti was informed that the probe involved in the event was disposed of after the procedure and therefore was not available for investigation.Additionally, nti was informed that the nurse went to see the doctor as a precautionary measure and they indicated that the nurse had 3 burn spots on her eye and that she does not have any serious discomfort or any vision issues.The investigation will proceed, any additional findings will be updated via a follow-up report.
Event or Problem Description
Northgate technologies was made aware of the following event " the spyglass was passed into the patients bile duct and the stone was visualized through spyglass.The ehl probe was opened and passed down the working channel of the spyscope.It was connected to the generator properly.Once the physician went to step on the generator pedal the probe sparked and zapped near the connection of the probe end to the generator as the nurse was holding it.It was later communicated to me that the nurse had gotten something in [redacted the] eye and the lab was sending [redacted nurse] to get [redacted their] eyes checked.I was later told they found 3 burn spots on [redacted nurse's] eye and they are sending [redacted nurse] to the doctor." after further follow up with the initial reporter it was indicated that the nurse "went to see a doctor [redacted] as a precautionary measure.They indicated that [redacted nurse] had 3 burn spots on [redacted their] eye.While [redacted nurse] does not have any serious discomfort aor any vision issues [redacted nurse] wanted it reported and wants to make sure we reported it.".

• Brand Name: LITHOTRIPSY PROBE 1.9FR 375CM DS
• Common Device Name: INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• MDR Report Key: 11605803
• Report Number: 0001450997-2021-00002
• Device Sequence Number: 19738550
• Product Code: FFK
• UDI-Device Identifier: 00817183020448
• UDI-Public: 00817183020448
• Combination Product (Y/N): N
• PMA/510(K) Number: K130368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2021

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: 12/22/2023
• Device Model Number: 72-00322-0
• Device Catalogue Number: M00546620
• Device Lot Number: BSC14944
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other