MAUDE Adverse Event Report: GYRUS ACMI, INC. PCNL BALLOON/INFLATION DEVICE KIT, 8X15; CATHETER, NEPHROSTOMY

Model Number	BPCN0815K
Medical Device Problem Codes	Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation/inspection.Based on the results of the investigation, the box does not contain the correct product was identified.It is likely the result of cause linked to device ; however, a definitive root cause could not be established.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.C.
Event or Problem Description
It was observed that during the device evaluation, the balloon exhibited the product model of primary and secondary packaging did not match.There was no patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction to a previously submitted report.This event was reported in error, and it would be unlikely to cause or contribute to a death or a serious injury if it were to recur.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: PCNL BALLOON/INFLATION DEVICE KIT, 8X15
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23728402
• Report Number: 3011050570-2025-01402
• Device Sequence Number: 10231975
• Product Code: LJE
• UDI-Device Identifier: 00821925033016
• UDI-Public: 00821925033016
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K132383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: Other
• Device Model Number: BPCN0815K
• Device Lot Number: 25037006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 12/05/2025
• 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): Yes
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FY26-022-A
• Patient Sequence Number: 1
• Patient Sex: Unknown