MAUDE Adverse Event Report: GYRUS ACMI, INC. BALLOON INFLATION DEVICE; DILATOR, URETHRAL

Model Number	BINF2530
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the balloon burst during a procedure.Maximum atmosphere 17 was used and the balloon did not fold out properly.The user suspected the inflation device was incorrect.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.There was no harm or user injury reported due to the event.This report is for the balloon inflation device.The balloon (model bpcn1015) is being reported on the medwatch with patient identifier (b)(6).
Additional Manufacturer Narrative
The suspect device was not sent to olympus for evaluation.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
Additional information was received from the customer.The procedure was a percutaneous nephrolithotomy which was completed with a device from another manufacturer.There was no effect on the patient due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information that was received from the user facility regarding the reported issue.Information provided in b3 and b5.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The lot number provided in the file was considered a non-valid lot number for the device.Because of this the dhr review is unable to be performed.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 balloon burst was reported to have been caused by an incorrect balloon inflation device, the gauge is inaccurate.Olympus will continue to monitor field performance for this device.

• Brand Name: BALLOON INFLATION DEVICE
• Common Device Name: DILATOR, URETHRAL
• 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: 15945808
• Report Number: 3003790304-2022-00327
• Device Sequence Number: 6346787
• Product Code: KOE
• UDI-Device Identifier: 00856877002414
• UDI-Public: 00856877002414
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K032840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2023

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 Expiration Date: 11/30/2024
• Device Model Number: BINF2530
• Device Catalogue Number: BINF2530
• Device Lot Number: 96460050
• 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: 10/07/2022
• Supplement Date Received by Manufacturer: 12/16/2022; 04/12/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 12/16/2022; 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BPCN1015: OLYMPUS BALLOON.
• Patient Sex: Unknown