MAUDE Adverse Event Report: GYRUS ACMI, INC EZDILATE BALLOON DILATOR (WG) 11-12-13; DILATION BALLOON

Model Number	BD-410X-1355
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During an esophageal dilatation surgery, the balloon was pumped to 2 atm ( max.5.5.Atm) and suddenly cracked.No patient injury was reported.
Additional Manufacturer Narrative
The balloon was discarded and will not be returned for evaluation.The investigation is on-going.If additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: EZDILATE BALLOON DILATOR (WG) 11-12-13
• Common Device Name: DILATION BALLOON
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 800 west park drive; westborough, MA 01581 ; 4848965250
• MDR Report Key: 14434629
• Report Number: 3003790304-2022-00075
• Device Sequence Number: 14692802
• Product Code: PID
• UDI-Device Identifier: 00821925033245
• UDI-Public: 00821925033245
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K143609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

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: BD-410X-1355
• Device Lot Number: 513069D
• 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: 05/15/2020
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2019
• 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