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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found one other complaint on lot number 10010757.The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.B3: date is unknown.
Event or Problem Description
According to the available information the wire broke during use.The same product was used from their inventory as a replacement.User suffered no harm.
Event or Problem Description
According to the available information the wire broke during use.The same product was used from their inventory as a replacement.User suffered no harm.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we find other complaint on lot number.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.We did not received the sample, upon receipt complaint will be reopened and updated.According to the picture received, we can see that the basket was not completely opened but without the sample, no investigation can be done and no root cause identified.

• 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
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 22730636
• Report Number: 9610711-2025-00129
• Device Sequence Number: 8967944
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EXN934
• Device Lot Number: 10010757_EXN9344002
• 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: 08/06/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• 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
• Patient Sex: Unknown