MAUDE Adverse Event Report: COLOPLAST A/S DRM 4 HEL W/O FILIF CH2.5 120; URETERAL STONE DISLODGER

Model Number DOR6341002

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, during a kidney stone extraction procedure, the device was not working.Despite a positive test before use, it did not work during the procedure.This defect doubled the procedure time and resulted in incomplete extraction of kidney stones.Therefore, the patient will have a new intervention.

Event Description

Additional information received from the hospital.The stone was at the middle chalice.The initial size of the stone was 15mm.The endoscope used is a flexible one.Laser was not used.No difficulties while using the dormia (tortuous path).

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the evaluation and the updated event information.After receiving this complaint, we could not search for other complaint as the lot number is not available.This complaint will be used for trend analysis.No sample available to perform investigation.Since ce marking no similar case dor634 was found.The dormia dor634 was used to dislodge or remove stones from middle calyx.Such medical device should only be used by trained professionals and is not intended to be used through a flexible endoscope.In this case, the use of the device through a flexible endoscope was associated with an incident of non-functional dor634.We believe the root cause is due by a misuse ( use of a flexible endoscope).Based on the above this complaint is not confirmed as a product defect.

• Brand Name: DRM 4 HEL W/O FILIF CH2.5 120
• Type of Device: URETERAL STONE DISLODGER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8268686
• MDR Text Key: 133788219
• Report Number: 9610711-2019-00003
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: DOR6341002
• Device Catalogue Number: DOR634
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/24/2018
• Initial Date FDA Received: 01/22/2019
• Supplement Dates Manufacturer Received: 12/24/2018
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other