MAUDE Adverse Event Report: COLOPLAST A/S PERCUTANEOUS NEPHROSTOMY DILATOR; ENDOSCOPIC-ACCESS DILATOR, SINGLE-USE

Catalog Number	RBB010
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
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 in (b)(6) 2025, a 0.038 guidewire failed to pass the guidewire through the dilator.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find other complaints on the lot number 10206626.The issue described concernent set of dilators component which include three size of dilator with references: ch06 (size incriminated in the complaint): yd140670 lot 9865202 (manufactured in august 2024) ch08: yd140870 lot 9830525 (manufactured in august 2024) & 9865204 (manufactured in july 2024) ch10: yd141070 lot 9834973 (manufactured in july 2024).Checking the quality database, revealed one non-conformity: "yd14xx70 passage du mandrin de contrôle de 1.00mm non conforme"" opened on june 2024 related to the described defect.This defect was due to a manufacturing issue and all actions have been implemented since january 2025.A rmf evaluation was performed based on criq266, risk identified 11207 (hazardous situation: dilator cannot glide over the guidewire (or with difficulty)).The evaluation has showed that risks are adequately controlled and reduced as far as possible in the state of art.Based on this, we can concluded 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/used.It is concluded that the risks identified are still acceptable and considered as safe.
Event or Problem Description
According to the available information in (b)(6) 2025, a 0.038 guidewire failed to pass the guidewire through the dilator.

• Brand Name: PERCUTANEOUS NEPHROSTOMY DILATOR
• Common Device Name: ENDOSCOPIC-ACCESS DILATOR, 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: 23477560
• Report Number: 9610711-2025-00460
• Device Sequence Number: 13401525
• Product Code: EZN
• UDI-Device Identifier: 03600040953761
• UDI-Public: 3600040953761
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170531
• 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): 02/04/2026

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: RBB010
• Device Lot Number: 10206626_RBB0104002
• Was Device Available for Evaluation?: No
• 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: 11/05/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• 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