MAUDE Adverse Event Report: COLOPLAST A/S DORMIA NO TIP CH03 90 CM; DORMIA STONE DISLODGER

Model Number EXN4341002

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2014

Event Type  malfunction  

Event Description

Incident report received from (b)(6).Basket detached during procedure and was left in the patient.The surgeon was able to remove it, but this resulted in a lengthening of the duration of surgery and anesthesia.No clinical consequences observed, lengthening of the time of the anesthesia.Per phone update 01/6/2015 : no patient consequence.Longer administration of gas anesthesia, but no new type of anesthesia introduced.

Manufacturer Narrative

The device is not available for evaluation.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 the device or additional information be received, a follow-up report will be filed.

• Brand Name: DORMIA NO TIP CH03 90 CM
• Type of Device: DORMIA STONE DISLODGER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE SAS; 9 avenue edmond rostand; sarlat-la-canéda, 2420 6; FR 24206
• Manufacturer Contact: megan daniel ; 1601 w river rd n; minneapolis, MN 55411 ; 6123024930
• MDR Report Key: 4470631
• MDR Text Key: 21776297
• Report Number: 9610711-2015-00001
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K900269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2015

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
• Device Operator: Health Professional
• Device Model Number: EXN4341002
• Device Catalogue Number: EXN4341002
• Device Lot Number: 4100526
• Other Device ID Number: 03600040268483
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/16/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/31/2014
• Initial Date FDA Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention