MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN EXTRACTION BALLOON V

Model Number B-V442Q-A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During an ercp, the subject device was used.In the procedure, the balloon of the subject device was broken and remained in the bile duct.The user could remove it with a grasping forceps of 3 wires.The intended procedure was completed with another device.There was no patient injury reported.The user reported the stone extracted from the patient was very large.This is the report regarding the breakage of balloon inside the bile duct.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The tube was separated at 360mm (at the joint) from the distal end.The tube was stretched at 1086mm from the root of the control section side.There was no abnormality found with the balloon and other malfunction which related to reported phenomenon was not found.The device history record was reviewed and found no irregularities.The exact cause of the reported event could not be conclusively determined.However, based on the evaluation result, it is likely the reported phenomenon was caused by following factors; the subject device was caught in the stone or a forceps elevator of the endoscope, it was difficult to remove the subject device from the patient bile duct.The excessive force was applied to the tube when the user pulled the subject device to try to remove it from the patient bile duct.The above device handling has warned in the instruction manual as follows; if resistance is too strong and withdrawal is difficult, adjust the angle of the endoscope until the instrument can be withdrawn smoothly.Forcible withdrawal of the instrument could damage the instrument and/or endoscope.When using an endoscope equipped with a forceps elevator, do not withdraw the instrument from the endoscope if the forceps elevator is up.This could damage the instrument.

• Brand Name: SINGLE USE 3-LUMEN EXTRACTION BALLOON V
• Type of Device: SINGLE USE 3-LUMEN EXTRACTION BALLOON
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8858485
• MDR Text Key: 194324552
• Report Number: 8010047-2019-02819
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B-V442Q-A
• Device Lot Number: 86V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1