MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME

Model Number	KD-411Q-0320
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, this device has not been recovered and returned.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
A customer reported to olympus that during endoscopic retrograde cholangiopancreatography, this disposable triple lumen sphincterotome was dislodged into the patient.It was not confirmed where it went and was not retrieved from the patient or the scope.An xray was performed after the procedure and the physician cannot confirm any needle was left in the patient.The procedure was completed with the same device.There were no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, although the root cause could not be determined, the following mechanism likely caused the detachment of the cutting wire: 1) the cutting wire was close to the tissue or endoscope.2) the output was activated 3) during activation, accidental discharge might have occurred at two points in the cutting wire at the same time.4) the discharge caused the cutting wire to become hot instantly.As a result, the cutting wire was broken and detached.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the wire is very short, the output is too high or activated while the wire touches metal parts of the endoscope, or the wire is tightened too strong.When the wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled.If the slider is pushed, the wire will be pushed out toward the papilla or move sideways.If the wire breaks off, stop the output immediately and pull the slider completely to retract the broken wire into the tube.Then withdraw the instrument from the papilla.Otherwise, patient injury, such as perforations, bleeding, or lacerations within the biliary duct and/or damage of the endoscope could result.¿ ¿be sure that the rear end of the cutting wire is extended from the distal end of the endoscope.In case the cutting wire contacts the forceps elevator, insufficient output or unintended tissue injury may occur.¿ olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME
• Common Device Name: DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16134154
• Report Number: 9614641-2023-00030
• Device Sequence Number: 7636581
• Product Code: KNS
• UDI-Device Identifier: 04953170041945
• UDI-Public: 04953170041945
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K950166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2023

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
• Operator of Device: Health Professional
• Device Model Number: KD-411Q-0320
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TJF-Q190V WITH SERIAL (B)(4).
• Patient Sex: Unknown