MAUDE Adverse Event Report: GYRUS ACMI, INC. INFLATION DEVICE (DISPOSABLE) FOR EBD; BALLOON INFLATOR

Model Number	MAJ-1740
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The customer reported that the during an unknown procedure, the inflation device for endoscopic balloon dilatation was being used.It was primed with sterile water to the fill line and attached to a third-party cre fixed wire balloon in 2 millimeter (mm)/13.5mm/15mm size.Upon dilation.It was noted after the third stretch that the balloon would no longer inflate.The balloon was deflated and removed.A new balloon in 12mm/13.5mm/15mm size was reinserted and upon inflation to 13.5mm, it lost pressure and the patient even remarked that she could feel that.The balloon was immediately removed and was noted to have burst.There was no harm or user injury reported due to the event.This event is reported under the following patient identifiers: (b)(6) - inflation device (1/2).(b)(6) - inflation device (2/2).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information provided by the customer.
Event or Problem Description
The patient did not experience any pain but did feel the balloon pop.There were no retained fragments from the balloon bursting.The event occurred during the therapeutic procedure (esophageal dilatation) and was completed with a similar device.There was a 10¿15-minute delay to switch devices.There was no harm or user injury reported due to the event.This event is reported under the following patient identifiers: (b)(6) ¿ inflation device (1/4).(b)(6) ¿ inflation device (2/4).(b)(6) - inflation device (3/4).(b)(6) - inflation device (4/4).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the original equipment manufacturers (oem) final investigation and a correction to d4.D4: the lot number is corrected to 'unknown' as the oem could not confirm the lot number provided.The device history record was unable to be reviewed for this device since the lot number could not be confirmed.Therefore, the device manufacturer date is unknown.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 complaints for this device.

• Brand Name: INFLATION DEVICE (DISPOSABLE) FOR EBD
• Common Device Name: BALLOON INFLATOR
• 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: 17406601
• Report Number: 3003790304-2023-00296
• Device Sequence Number: 12243185
• Product Code: KOE
• UDI-Device Identifier: 00856877002537
• UDI-Public: 00856877002537
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K032840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2024

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: MAJ-1740
• Device Lot Number: 30490973
• 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: 06/30/2023
• Supplement Date Received by Manufacturer: 08/28/2023; 04/16/2024
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 09/01/2023; 04/26/2024
• 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