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	Difficult to Open or Close (2921); Material Deformation (2976); Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, during an ureteroscopy for a kidney stone, the dormia device in question was not functioning properly.The small basket at the tip of the dormia was broken and no longer had its usual shape, which prevented the surgeon from properly grasping the stone.A new device was provided.This resulted in wasted time and an extended procedure duration.
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, during an ureteroscopy for a kidney stone, the dormia device in question was not functioning properly.The small basket at the tip of the dormia was broken and no longer had its usual shape, which prevented the surgeon from properly grasping the stone.A new device was provided.This resulted in wasted time and an extended procedure duration.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint, and we didn¿t find other complaints on the lot indicated in the description.On 09th april 2026, we received the defective sample from the user.During the investigation of the defective device, the absence of glue revealed that the dormia had been disassembled by the customer and had been incorrectly reassembled.The damages present on the dormia has showed than excessive force was applied to the device during its use.After disassemble and reassemble the dormia, the basket become perfectly functionnal.All these observations lead us to conclude that our device has not used correctly.Checking the quality databases revealed no anomaly in connection with the described defect.The dormia is a fragile medical device which must be handled with care.In addition, our documentation reveals a 100% inspection is performed following our work instruction: - 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.

• 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 (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat la canéda cedex 24200 ; FR 24200
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 24839375
• Report Number: 9610711-2026-00124
• Device Sequence Number: 18524646
• Product Code: FFL
• UDI-Device Identifier: 03600040955529
• UDI-Public: 3600040955529
• 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): 06/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EXN734
• Device Lot Number: 10562132_EXN7344002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown