MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (FW) 16-17-18; DILATOR, ESOPHAGEAL

Model Number	BD-400P-1880
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An olympus representative contacted the olympus technical assistance center (tac), to report a balloon pop upon inflation during a esophageal dilation procedure.Further inquiry with customer revealed the balloon popped but didn¿t fall into patient.It was still attached to the catheter and pulled through the scope.The procedure was completed with a similar device without delay.There was no patient injury or harm due to the device malfunction.
Additional Manufacturer Narrative
The device was not sent to olympus for evaluation as the box was saved but not the device itself.The investigation is ongoing.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.Please see updates to h6 and h10.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was not returned.Based on the results of the investigation, the root cause of this event (balloon popped) was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: EZDILATE BALLOON DILATOR (FW) 16-17-18
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): GYRUS ACMI, INC.; gyrus acmi, inc.; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15391117
• Report Number: 3005975494-2022-00039
• Device Sequence Number: 12026041
• Product Code: KNQ
• UDI-Device Identifier: 00821925033207
• UDI-Public: 00821925033207
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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-400P-1880
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown