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

Catalog Number	RBA008
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information there was dirt on the tip of 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-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18522270
• Report Number: 9610711-2024-00019
• Device Sequence Number: 11651251
• Product Code: EZN
• UDI-Device Identifier: 03600040255728
• UDI-Public: 3600040255728
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 01/16/2024

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 Expiration Date: 02/05/2025
• Device Catalogue Number: RBA008
• Device Lot Number: 7486361_RBA0081002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2024
• Date Device Manufactured: 05/26/2020
• 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