MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (FW) 8.5-9.5-10.5; OESOPHAGEAL BALLOON CATHETER

Model Number	BD-400P-1080
Medical Device Problem Codes	Mechanical Problem (1384); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned for evaluation.Per the information noted by the technical assistance center (tac) support engineer, the customer will not be returning the item at this time.No further information provided as to why the device is not returning.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported that while holding pressure at 9.5 atm (atmospheric pressure), the device was suddenly lost pressure.Upon inspection, it was found the balloon had split down the side.The device was replaced and the intended diagnostic an unspecified procedure was completed using another dilator balloon (similar device).There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction: e2 was inadvertently checked; reporters title is not available.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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.A formal investigation was initiated to investigate the root cause.Olympus will continue to monitor field performance for this device.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 8.5-9.5-10.5
• Common Device Name: OESOPHAGEAL 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: 17387122
• Report Number: 3003790304-2023-00293
• Device Sequence Number: 6183097
• Product Code: KNQ
• UDI-Device Identifier: 00821925033177
• UDI-Public: 00821925033177
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT-KNQ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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 Expiration Date: 03/01/2024
• Device Model Number: BD-400P-1080
• Device Lot Number: 300113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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