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

Model Number	KD-401Q-0320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer report to olympus that during a therapeutic endoscopic retrograde cholangiopancreatography (ercp), it was reported that the sphinctertome wire snapped.The procedure was extended an additional ten minutes to locate the wire that was possibly lodged inside the patient.The procedure was completed using a replacement device.No additional treatment was required.There was no reported patient harm associated with this event.
Additional Manufacturer Narrative
The subject device was not returned to olympus for evaluation.The condition of device could not be confirmed.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported device problem.The dhr confirmed that the subject device was shipped in accordance with the specifications.A spark was generated by energization and the knife wire dropped.However, a definitive root cause could not be determined.The instruction manual provides the following: ¿ 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16564309
• Report Number: 9614641-2023-00390
• Device Sequence Number: 14875642
• Product Code: KNS
• UDI-Device Identifier: 04953170041587
• UDI-Public: 04953170041587
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K950166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/17/2023

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-401Q-0320
• Device Lot Number: 19K OR 21K
• 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: 02/15/2023
• Initial Report FDA Received Date: 03/17/2023
• 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
• Patient Sex: Unknown