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

Model Number	BD-VC431Q-1840-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the balloon dilator knife wire broke when the physician turned on the electricity during a duodenal papillotomy procedure.The procedure was completed with a replacement device.There was no patient harm associated with the event.
Additional Manufacturer Narrative
The device was returned and an investigation confirmed the reported allegation.The broken part of the knife wire was melted and burnt, and the wire sheath was torn.Some of the wire covering was damaged.When the outer diameter of the knife wire was measured, there was no abnormality.When the length of the knife wire and wire coating was measured, the wire coating on the tip side was missing about 11.5 to 16.5 mm.Other than the above, no abnormalities were found in the actual product.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

• 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15464869
• Report Number: 9614641-2022-00345
• Device Sequence Number: 6902797
• Product Code: KNS
• UDI-Device Identifier: 04953170373992
• UDI-Public: 04953170373992
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2022

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-1840-30
• Device Lot Number: 14K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• 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: 08/23/2022
• Initial Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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: BIO300D; CLV-290 (LIGHT SOURCE); CV-290 (VIDEO PROCESSOR); JF-260V (FLEX VIDEO SCOPE)
• Patient Sex: Unknown