MAUDE Adverse Event Report: COLOPLAST A/S DORMIA; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number EXN7341002

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Five used samples were received for analysis.Visual examination revealed the screw was screwed but the wires for each were broken.Examination under magnification revealed the material of the wire was melted, likely due to high temperatures during use (e.G.Laser).The cause of the event was likely due to the user not following recommendations within the instructions for use that state: "any contact with stone fragmenting device may damage the wires of the basket" and "take care to avoid all contact with between the extractor and any electrical medical device.".

Event Description

According to the available information, five physicians indicated that during the procedure the wires were coming off the basket (from one to all four wires).

• Brand Name: DORMIA
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12868970
• MDR Text Key: 281205548
• Report Number: 9610711-2021-00112
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2023
• Device Model Number: EXN7341002
• Device Catalogue Number: EXN734
• Device Lot Number: 8012257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1