MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (FW) 16-17-18; ENDO THER, NON-EN

Model Number BD-400P-1880

Device Problems Crack (1135); Deflation Problem (1149)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

It was reported to olympus by a territory manager, that the device (balloon dilator) failed upon initial clinical use.The physician inflated the balloon, during the second time, the grey hub seemed to have a crack in it, causing a leak outside of the patient.The balloon had to be cut off since they could not deflate.There was no error messages, the procedure was no delayed or rescheduled.The patient was not affected by the reported issue.The procedure being performed was an esophageal dilation.A new balloon was opened to finish the procedure.The olympus inflation device syringe was connected to the balloon at the time.There was no patient injury or adverse event reported to olympus.

Manufacturer Narrative

The device was not returned to olympus for evaluation and repair.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the suggested event occurred due to that occlusion partial or total was generated in the proximal bonding station due to misalignment of the d-mandrel or mandrel during the preparation for bonding process.The operator has not enough visibility to ensure the correct position of the d-mandrel or mandrel, causing melting material smearing occluding partial or total the diameter of the extrude.Causing two events, the first is the diameter is completely occluded which would prevent the balloon from inflating.And the second event would be that the diameter is partially occluded which would cause it to take longer to inflate or deflate.However, the root cause of the suggested event could not be determined.Olympus will continue to monitor field performance for this device.

Event Description

No error messages that may have been observed because of the failure.The procedure was therapeutic and the problem minimally prolonged the procedure but did not affect outcome or patient.No medical intervention needed.The olympus inflation device syringe was connected to the balloon at the time.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 16-17-18
• Type of Device: ENDO THER, NON-EN
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17260785
• MDR Text Key: 318474632
• Report Number: 3011050570-2023-00080
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT-KNQ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD-400P-1880
• Device Lot Number: 382273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• 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: OLYMPUS INFLATION DEVICE SYRINGE.