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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
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 after crushing the calculus, the basket holding the calculus broke when pulling the dormia out of the retrace.The broken basket was recovered using forceps.A laser was used, but since it was not used at the same time, interference is unlikely.There were no adverse effects on the patient's health.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find other complaints on the lot number on the same defect.In september 2025, we received one used sample broken in two parts.The basket was detached from the sheat and the handle part.The sheath part was damaged at the end of the handle and the orange sheat was broken and wrinkled.This issue could be occurred when sheat cannot be move freely, or when a damage blocked sheat¿s movement.The basket was separate from the sheat and we could observed the welding impacts on the metallic part so the welding was well done during manufacturing.We also observed one wire cut; this kind of cut can be done with laser or sharp instrument.Basket seem broken at the extremity.These defects could be observed when dormia was already used and an excess of force was applied on this medical device.According to the description calculus could be block at the retrace orifice, force applied on this medical could be led to a rupture.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.A similar case study was performed on dormia no-tip/n-stone on the defect "damaged/broken" from may 2021 to may 2025; 67 similar cases were found.A rmf evaluation was performed based on criq269, risk identified 11359 (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 after crushing the calculus, the basket holding the calculus broke when pulling the dormia out of the retrace.The broken basket was recovered using forceps.A laser was used, but since it was not used at the same time, interference is unlikely.There were no adverse effects on the patient's health.

• 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: 23075440
• Report Number: 9610711-2025-00397
• Device Sequence Number: 10064737
• Product Code: FFL
• UDI-Device Identifier: 03600040955581
• UDI-Public: 3600040955581
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/05/2026

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: EXN934
• Device Lot Number: 10020274_EXN9344002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• 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: 09/17/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown