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	02/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, attempted to retrieve the stone using the product, but the basket's range of motion on the operating handle side was too limited.This prevented the tip from fully retracting during stone retrieval, necessitating discontinuation of use.Another unit from the same lot was used, but the same malfunction occurred, preventing stone retrieval and requiring discontinuation of the procedure.The basket is not broken.
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, attempted to retrieve the stone using the product, but the basket's range of motion on the operating handle side was too limited.This prevented the tip from fully retracting during stone retrieval, necessitating discontinuation of use.Another unit from the same lot was used, but the same malfunction occurred, preventing stone retrieval and requiring discontinuation of the procedure.The basket is not broken.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint, and we find one other complaint on the lot number.On (b)(6) 2026, we have received 2 used samples.After decontamination, we obseved several defects on each sample.Sample 1: -cristal sheath broken in the middle.-cristal cheath bended close to the cristal reinforcement.-orange sheath seems to be wrikled inside the handle, caused by an excessive force on the device.-basket too much outside: 2.5mm (measured with ruler reg0021) -basket can be moved easily and can be open and close.After unfolding the orange sheath, the lenght between the basket and the sheath is no more than 1.5mm (mesured with ruler reg0021).According to the fsi, in open position, the basket must not extend more than 2mm.In this case, our device is conform of our dimentional specifications and no defect can be observed for the issue mentionned in the description.Sample 2.-cristal sheath broken in the middle.-orange sheath seems to be wrikled inside the handle, caused by an excessive force on the device.-basket too much outside: 3.0mm (measured with ruler reg0021) -basket can be moved easily and can be open and close.After unfold the orange sheath, the lenght between the basket and the sheath is no more than 1.5mm (measured with ruler reg0021).According to the fsi, in open position, the basket must not extend more than 2mm.In this case, our device is conforming to our dimentional specifications and no defect can be observed for the issue mentioned in the description.Checking the work order does not reveal any anomalies during the manufacturing process.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: 24673578
• Report Number: 9610711-2026-00093
• Device Sequence Number: 13298155
• Product Code: FFL
• 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): 05/28/2026

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: 10397079_EXN9344002
• Date Returned to Manufacturer: 03/20/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• 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: 03/24/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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