MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (FW) 18-19-20

Model Number	BD-400P-2080
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus that the ezdilate balloon dilator (fw) 18-19-20 balloons are not deflating.The event occurred during a therapeutic procedure.There was no patient harm associated with the event.
Additional Manufacturer Narrative
A review of the device history record found no deviations that could have caused or contributed to the reported issue.The h8 field was corrected, as it was unintentionally was left blank un the initial medwatch.The device was not returned to olympus for evaluation and therefore the customer's allegation was not confirmed.Based on the results of the investigation, the nonconformance observed in this complaint was categorized as a process defect.An exhaustive revision of the process was completed, founding 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.Olympus will continue to monitor field performance for this device.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 18-19-20
• Common Device Name: DILATOR
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18019838
• Report Number: 3003790304-2023-00413
• Device Sequence Number: 6643174
• Product Code: KNQ
• UDI-Device Identifier: 00821925033214
• UDI-Public: 00821925033214
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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-400P-2080
• Device Lot Number: 376574
• Was Device Available for Evaluation?: No
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown