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

Model Number	BD-410X-2055
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided.
Event or Problem Description
The customer reported that the popped during the procedure.The procedure was completed with another balloon.The procedure was prolonged by 5 to 10 minutes and the patient's anesthesia was extended by 15 to 20 minutes.The minor extension of the procedure and anesthesia poses no additional harm, and the patient was confirmed to have had no impact from the failure.There were no reports of harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to b5, d10, and g2 for information inadvertently left out of previous report.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, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported that the balloon popped during a esophagogastroduodenoscopy (egd).The balloon was cut to retrieve it from the scope.

• Brand Name: EZDILATE BALLOON DILATOR (WG) 18-19-20
• Common Device Name: BALLOON 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: 17655185
• Report Number: 3003790304-2023-00344
• Device Sequence Number: 20650345
• Product Code: FGE
• UDI-Device Identifier: 00821925033276
• UDI-Public: 00821925033276
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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-410X-2055
• Device Lot Number: 386463
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• 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: MAJ-1740 INFLATION DEVICE.
• Patient Sex: Unknown