MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (WG) 13.5-14.5-15.5

Model Number	BD-410X-1555
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a colonoscopy procedure, the balloon exploded inside of the patient when the nurse was inflating.They had attempted to reach 15 mmhg but this was impossible, and the balloon burst at 6 mmhg.The doctor was not able to remove the balloon from the scope, so they had to remove the scope from the patient, cut the balloon, and repeat the procedure with a different device.There were reports of no fragments retained after the balloon burst.It took some time to the get another balloon and no additional sedation was required.The condition of the patient was not affected by the failure.The patient is reported to be fine post-procedure.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's (lm) investigation.Olympus received a box of five unused devices from the same lot.However, the subject device (involved in this reported event) was discarded and not returned to olympus for evaluation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, the reported failure could not be confirmed as the subject device was not returned for evaluation.Therefore, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which states: "warning: do not insert this instrument when the endoscope is angulated.This could damage the endoscope and/or this instrument.Do not angulate the bending section of the endoscope abruptly while the needle is inserted into the instrument channel of the endoscope.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.".This supplemental report includes an update to h3 from the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: EZDILATE BALLOON DILATOR (WG) 13.5-14.5-15.5
• Common Device Name: EZDILATE BALLOON DILATOR (WG) 13.5-14.5-15.5
• 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: 20369141
• Report Number: 3011050570-2024-00407
• Device Sequence Number: 3889851
• Product Code: FGE
• UDI-Device Identifier: 00821925033252
• UDI-Public: 00821925033252
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BD-410X-1555
• Device Lot Number: 408353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown