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

Catalog Number	EXN734
Medical Device Problem Codes	Material Separation (1562); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, the stone basket split into 2 parts and could no longer be used.Another basket had to be opened.No harm to user.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints, and we didn't find any other complaints on lot number 10142963.The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.B3: date is unknown.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't found any others complaints on lot number 10142963.On description we cannot determined where the dormia was broken, without answer and sample we cannot determine any root cause.According to the informations known quality databases was checked and revealed no anomaly in relation to the described defect.A similar case study was performed based on dormia no-tip product, defect: broken from may 2021 to may 2025, 23 similar cases were found.A rmf evaluation was performed based on criq 269 - risk identified 11356 (hazardous situation: basket cannot be opened/closed several times - metallic part breaks) 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.
Event or Problem Description
According to the available information, the stone basket split into 2 parts and could no longer be used.Another basket had to be opened.No harm to user.

• 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: 22122876
• Report Number: 9610711-2025-00089
• Device Sequence Number: 7175926
• Product Code: FFL
• UDI-Device Identifier: 03600040955529
• UDI-Public: 3600040955529
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/20/2025

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 Catalogue Number: EXN734
• Device Lot Number: 10142963_EXN7344002
• Was Device Available for Evaluation?: No
• 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: 06/02/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2025
• 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