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

Model Number	BD-VC431Q-1840-25
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In addition to the findings in b5, evaluation found the knife wire was deformed and bent, foreign matter was attached to the knife wire and the wire sheathing was torn.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although a definitive root cause of the deformed knife wire and the cover was peeled and knife wire was exposed could not be determined, likely factors causing the defect could have been the following: based on the investigation result, it is possible that a force was applied to the distal end of the device during device handling as described below.This might have caused the cutting wire to deform.·when pre-curved stylet was removed.·when an attempt was made to curve the distal end of the tube.·when the device was inserted into the endoscope.·when an attempt was made to extend the distal end of the tube while the forceps elevator was raised.A likely factor causing tears of the coated portion of the cutting wire might be the following.However, the exact cause could not be determined.·the knife wire was deformed and the coated portion of the cutting wire has possibly been rubbed due to the effect of contacting a metal area of the endoscope.·it is possible that the slider was slightly pushed causing the cutting wire to deflect.The coated portion of the cutting wire has possibly been rubbed due to the effect of contacting a metal area of the endoscope.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported, the balloon dilator v with knife the cover was peeled and the knife wire was exposed.The issue occurred during a endoscopic retrograde cholangiopancreatography procedure.The procedure was completed using a similar device.There were no reports of patient harm or injury.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18765062
• Report Number: 9614641-2024-00457
• Device Sequence Number: 14577675
• Product Code: KNS
• UDI-Device Identifier: 04953170373978
• UDI-Public: 04953170373978
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150142
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/23/2024

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-1840-25
• Device Lot Number: 02K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• 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: 01/05/2021
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2020
• 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: JF-260V.
• Patient Sex: Unknown