MAUDE Adverse Event Report: GYRUS ACMI, INC. INFLATION DEVICE (DISPOSABLE) FOR EBD; CATHETER/OVERTUBE BALLOON INFLATOR, SINGLE-USE

Model Number MAJ-1740

Device Problem Inflation Problem (1310)

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

The customer reported that the subject device was being used during a therapeutic esophageal dilatation procedure.It was primed with sterile water to the fill line and attached to a non-olympus cre fixed wire balloon in 12 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 felt the balloon pop.Reportedly, the patient did not experience any pain.The balloon was immediately removed and was noted to have burst.There were no retained fragments from the balloon bursting.The intended procedure was completed using another device.The procedure was delayed for less than 10-15 minutes because they had to use multiple balloons and multiple inflation devices.There was no harm or user injury reported due to the event.Related reports are being submitted on the medwatch with patient identifier: (b)(6).

Manufacturer Narrative

H4 device manufacturer date: date of manufacture cannot be determined since the lot number was not provided.The subject device is not expected to be returned to olympus for further evaluation and testing.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Manufacturer Narrative

This report is being supplemented to correct information provided in the initial medwatch report.Correction to information provided in g3 of the initial medwatch report: the aware date (date received by manufacturer) should have been 23aug2023.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the original equipment manufacturers (oem) final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.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
• Type of Device: CATHETER/OVERTUBE BALLOON INFLATOR, SINGLE-USE
• 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: 17725782
• MDR Text Key: 323171630
• Report Number: 3003790304-2023-00358
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 00856877002537
• UDI-Public: 00856877002537
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K032840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: MAJ-1740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 10/23/2023; 04/26/2024
• Supplement Dates FDA Received: 10/24/2023; 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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