MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE BALLOON DILATOR V (WITH KNIFE)

Model Number	BD-VC431Q-1240-25
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device was returned for evaluation.During examination, the reported issue could be confirmed: the knife wire was damaged.In addition, the knife wire was coming out from the tube with the knife tip.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The customer reported that the balloon dilator was in use for a therapeutic endoscopic sphincterotomy.The customer reported the extraction basket they were using became incarcerated with the dilator.After that, the customer cut the dilator's sheath but basket was still incarcerated.When user tried to forcefully to insert the product the tip of the knife wire broke.The wire tip did not fall off.The procedure was completed with a new device of the same model number.No adverse effects to patient reported.
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 result of confirmation of the device, and the similar investigation results in the past, a likely mechanism causing the cutting wire breakage may be the following: 1.The cutting wire came into contact with the distal end of the endoscope when the forceps elevator was raised.2.Under circumstances described above 1, an electric conduction was activated.This caused the cutting wire to become hot instantly at the contact point.As a result, the cutting wire broke.However, the exact cause of the problem could not be conclusively identified.This instruction manual contains the following information that may prevent the event: "since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the cutting wire is very short, the output is too high or activated while the cutting wire touches metal parts of the endoscope, or the cutting wire is tightened too strong.When the cutting wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled.If the slider is pushed, the cutting wire will be pushed out toward the papilla or move sideways.If the cutting wire breaks off, stop the output immediately and pull the slider completely to retract the broken cutting wire into the tube.Then withdraw the sphincterotome from the papilla.Otherwise, patient injury, such as perforations, bleeding, or lacerations within the biliary duct, and/or damage of the endoscope could result." "when inserting the instrument into the endoscope, be sure that the cutting wire is parallel to the tube.Otherwise, the metal part of the forceps elevator may contact the cutting wire and peel off the coating material." "do not activate output while tissue is in contact with the torn or damaged coated portion of the distal end.If output is activated while tissue is contacting the torn or damaged coated portion due to insertion into or withdrawal from an endoscope, leakage current, decreased output, and/or thermal injury could result." "if you feel the cutting is blunt, withdraw the device from the scope to examine if there is any peel off and tear at the coating portion." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE BALLOON DILATOR V (WITH KNIFE)
• Common Device Name: BALLOON DILATOR
• 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: 18345613
• Report Number: 9614641-2023-01932
• Device Sequence Number: 5380697
• Product Code: KNS
• UDI-Device Identifier: 04953170414107
• UDI-Public: 04953170414107
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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: BD-VC431Q-1240-25
• Device Lot Number: 33K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2023
• 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: VIO ELECTROSURGICAL UNIT; ZEON CRUSHER BASKET
• Patient Sex: Unknown