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

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 olympus field corrective action administrator reported (on behalf of the customer) that the balloon does not deflate well, therefore was unable to pull the balloon out while using the evis exera iii gastrointestinal videoscope.It was noted that to pull out the balloon, the entire endoscope was withdrawn from the patient then the balloon part was cut.There was no patient harm associated with the event.

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.Three attempts were performed to obtain additional information, but no response was received from the customer.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Three attempts were performed to obtain additional information, but no response was received from the customer.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause of the reported event is unable to be determined.If additional information becomes available, this report will be supplemented accordingly.Olympus will continue to monitor field performance for this device.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 18-19-20
• Type of Device: DILATOR, ESOPHAGEAL
• 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: 18338648
• MDR Text Key: 331055603
• Report Number: 3003790304-2023-00451
• 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-KNQ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD-400P-2080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2024
• 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: Reuse
• Patient Sequence Number: 1