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	Fracture (1260); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.B3: estimated date.
Event or Problem Description
According to the available information the blue sheath detached from the basket and would not open or close when it had a stone in the basket.The basket was removed alongside the scope, and once out the patient it was not opening.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find other complaint on the lot number.Unfortunately no sample is available from the customer and no device of this batch number from our stock was available so we cannot go further than the documentary investigation which didn¿t reveal any anomaly recorded during production.Checking the quality databases did not reveal any anomaly in relation to the described defect.(b)(4).The dormia is packaged with the basket opened.A similar case study was performed on dormia no-tip/n stone, on the same defect "sheath damaged/broken" from (b)(6) 2021 to (b)(6) 2025: 18 similar cases were found.
Event or Problem Description
According to the available information the blue sheath detached from the basket and would not open or close when it had a stone in the basket.The basket was removed alongside the scope, and once out the patient it was not opening.

• 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: 23779423
• Report Number: 9610711-2025-00506
• Device Sequence Number: 10345550
• Product Code: FFL
• UDI-Device Identifier: 03600040955529
• UDI-Public: 3600040955529
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 04/29/2026

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: 10463219_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: 12/11/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2025
• 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