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Model Number 72-00322-0
Device Problems Device Emits Odor (1425); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Northgate technologies received notification from customer boston scientific on (b)(6) 2018 of an alleged event in that it was reported that "while using the ehl probe, it was noticed that the wire on tip of the probe was expose and the protective coating seem to be frayed, this was after one thousand shots in the common bile duct". And "there was a smell of smoke coming from the scope". Northgate technologies received two (2) probes on november 1, 2018 of parts 72-00322-0, autolith touch bsc ds probe 1. 9fr (french) 375cm, lot bsc13281 under rma# (b)(4), and rma# (b)(4) (complaints (b)(4) respectively). The autlith touch lithotripsy system is a bipolar electrosurgical modality which creates a spark between the center-conductor and tip of the probe in normal physiological saline to effect a cavitation bubble to hydraulically fracture calculi in the billiary system. The 1. 9 french probes are designed to last between 600 and 1200 shots, and the autolith touch generator provides an alert at 1100 shots, and ceases to allow operation beyond 1230 shots. The operating manual contains the warning, ". Regardless of the "replace probe" message, stop using immediately and use a new probe: firing (or arcing) behind the tip, ejection of tip or insulation material, arcing along the wires or inside /outside of the connector". Both probes were visually inspected. The probe under (b)(4) did not show any signs of degradation - the tip was in-tact, and epoxy was present with the center-conductor at the tip. The probe under (b)(4) was also visually inspected and it was determined "complaint verified, no tip. Based on the pictures, there is evidence of charring near the tip area which is caused by the probe firing behind the tip and/or after the tip has fallen off". This probe was inspected under a microscope where it was determined that the tip was missing, and the polyimide tubing showed limited signs of burn/charring. This is consistent with an end-of life failure of the probe where the probe is fired passed the indicated end-of-life. In this circumstance, the center-conductor disintegrates to the end of the probe tip, and dislodges the probe tip. Continued firing of the probe can begin to burn or char the polyimide tubing of the probe. This erosion of the polyimide poses no additional risk to the patients beyond the odor. The customer statement that the observation of "wire on the tip of the probe was exposed" is consistent with the statement of "this was after one thousand shots int he common bile duct". The probe under (b)(4) fired normally for 80 shots. No further issues were noted with this probe. A device history record review was conducted where it was determined that "a review of mo bsc13281 was performed and nothing out of the ordinary was found. The mo pass all tests on april 23, 2018". All probes are fired for 30-shots at the end of the production line, and lots are sampled for firing to the end of life, after-which they undergo a pull-test at the tip to ensure tip integrity at the end of life. Lot bsc13481 passed all in-process and final quality checks. The lot passed with an average shot count of 1201 shots, and a average tip pull force of 6. 74 lbs. Additionally the risk analysis was reviewed (document (b)(4)) for the tip coming off, where it was determined, "with respect to the tip falling off in section 7. 2. 12, "particle remaining in body that may cause blockage, possibly from distal tip detaching", the mitigation of that is that, "the tips can be removed by minimally invasive means or the tips will pass through the patients system with no harm to the patient". This report is being filed for the smell of smoke.
Event Description
It was reported that the ehl generator was set to high / 30 settings for a large bile duct stone case. The first ehl probe worked well and no complaints. While using the ehl probe, it was noticed that the wire on tip of the probe was expose and the protective coating seem to be frayed, this was after one thousand shots in the common bile duct. The second probe was removed after noticing the exposed wire. They subsequently placed another ehl probe down the same channel. Once they started firing shots and there was a smell of smoke coming from the scope. Based on the second probe having an exposed wire, the doctor did not feel faze in continuing to use the third probe when it started to smell.
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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 Key8121956
MDR Text Key130654018
Report Number0001450997-2018-00003
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 company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72-00322-0
Device Catalogue Number72-00322-0
Device Lot NumberBSC13281
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial