MAUDE Adverse Event Report: GYRUS ACMI, INC. EZDILATE BALLOON DILATOR (WG) 18-19-20; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	BD-410X-2055
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An olympus representative contacted the olympus technical assistance center (tac), to report 2 balloons popped in the patient and were removed without an additional procedure.There were no reports of patient harm associated with this event.
Additional Manufacturer Narrative
In speaking with olympus technical assistance center (tac), no troubleshooting was performed and the product was not returned.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.The following medwatch reports are related: patient identifiers (b)(6)(b)(4) and (b)(6) ((b)(4) , this complaint).
Additional Manufacturer Narrative
This report is to add h4, which was inadvertently left out of the first supplemental report.
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.Based on the results of the investigation and because the subject device was not returned, the reported event could not be confirmed and the root cause was unable to be determined.The balloon may be damaged during insertion or retrieval either through scrapping or gouging when passing through the endoscope or on staples, if present, in the patient¿s intestine.This may cause it to rupture.Olympus will continue to monitor field performance for this device.

• Brand Name: EZDILATE BALLOON DILATOR (WG) 18-19-20
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15776151
• Report Number: 3005975494-2022-00061
• Device Sequence Number: 12414896
• Product Code: FGE
• UDI-Device Identifier: 00821925033276
• UDI-Public: 00821925033276
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K180086
• 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,Followup
• Report Date (Section B): 03/09/2023

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-410X-2055
• Device Lot Number: 309774
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 02/13/2023; 03/08/2023
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 03/08/2023; 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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