MAUDE Adverse Event Report: COLOPLAST A/S DORMIA NO-TIP / N-STONE; URINARY STONE RETRIEVAL BASKET, SINGLE USE

Catalog Number	EXN934
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, the distal weld came undone during use.There were no clinical consequences for the patient.
Additional Manufacturer Narrative
The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.
Event or Problem Description
According to the available information, the distal weld came undone during use.There were no clinical consequences for the patient.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and none regarding the lot number 9956408.In april 2025, we received one used sample.After disinfection, the sample was tested, basket could be moved inside the sheath, however the basket cannot be opened due to the ring situated at the extremity of the basked slide along the wire.No other defect was observed on this medical device.One way to reproduce this defect is to slightly block the metal part and open the dormia.As the sheath moves forward, the wires advance and slide into the ring.We believe that this root cause may be due to the design of the product.Our supplier and the r&d department have been informed.Checking the quality databases did not reveal any anomaly in relation to the described defect.Note: the dormia is a fragile instrument which must be handled with care.However, our documentation reveals a 100% inspection is performed following our work instruction and inspections are documented: - control realized at 100% after the assembling: each step of the process - functionality (open/close) verified - after the packaging, visual controls at 100% during the packaging, an opening and closing test is performed three times and a checking that the basket is fully extended is performed.The dormia is packaged with the basket opened.The evaluation has showed that risks are adequately controlled and reduced as far as possible in the state of art level.Based on this, we can conclude that residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.It is concluded that the risks identified are still acceptable and considered as safe.

• Brand Name: DORMIA NO-TIP / N-STONE
• Common Device Name: URINARY STONE RETRIEVAL BASKET, SINGLE USE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 21868152
• Report Number: 9610711-2025-00073
• Device Sequence Number: 4721715
• Product Code: FFL
• UDI-Device Identifier: 03600040955581
• UDI-Public: 3600040955581
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: Health Professional
• Device Expiration Date: 10/02/2026
• Device Catalogue Number: EXN934
• Device Lot Number: 9956408_EXN9344002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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