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

Model Number BD-400P-2080

Device Problem Deflation Problem (1149)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, the ezdilate balloon dilator had a deflation issue during an unknown procedure.There were no reports of patient harm.

Manufacturer Narrative

The device was not returned to olympus for evaluation.A supplemental report will be submitted if any additional information is provided by the user facility.

Event Description

The procedure was esophageal dilation.The ez-dilate got stuck in the scope channel.The device was removed by cutting out of the channel.The procedure was prolonged 1-2 minutes due to the malfunction.The procedure was at the end of the procedure when the device malfunctioned.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction: g2 health professional was inadvertently missed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus and the original equipment manufacture conducted formal investigation which concluded this event was caused by a manufacturing process defect.Corrections and corrective actions have been implemented to prevent reoccurrence.Olympus will continue to monitor field performance for this device.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 18-19-20
• Type of Device: GASTROINTESTINAL BALLOON CATHETER
• 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: 17410296
• MDR Text Key: 320040669
• Report Number: 3003790304-2023-00303
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00821925033214
• UDI-Public: 00821925033214
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD-400P-2080
• Device Lot Number: 381391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• 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