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

Model Number BD-VC431Q-1840-30

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2022

Event Type  malfunction  

Event 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.

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)
• Type of Device: 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
• MDR Text Key: 306338919
• Report Number: 9614641-2022-00345
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170373992
• UDI-Public: 04953170373992
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BIO300D; CLV-290 (LIGHT SOURCE); CV-290 (VIDEO PROCESSOR); JF-260V (FLEX VIDEO SCOPE)