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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S DRM 4 HL WIRE W/O FILIF 90 DISLODGER, STONE, BASKET

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COLOPLAST A/S DRM 4 HL WIRE W/O FILIF 90 DISLODGER, STONE, BASKET Back to Search Results
Model Number DOR4241002
Device Problem Break (1069)
Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104); No Code Available (3191)
Event Date 03/05/2017
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 of 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, for the surgery a pentax endoscope and a dormia were used. They captured the stone, but it was not able to pass the papilla. Due to this they continued with the stone fragment device (the stone fragment device is a mechanical lithotriptor). During compression, the wire of the basket broke. Nevertheless, the fragmented stone could be removed with the broken basket and the endoscope. This resulted in a longitudinal crack of the duodenal wall with strong bleeding. Hemostasis was not possible. Due to this 2nd surgery (laparotomy) at the same day. After 2 more re-laparotomies and closure of fistula the patient improved. He was released from the hospital to outpatient treatment - subjectively he felt good. It is not clear which lot of the dormia was used, lots 10050286 and 10070002. Both lots expired in 2015. Dor424 is not indicated for biliary extraction, and for use with any lithotriptor. Device was probably expired.
 
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Brand NameDRM 4 HL WIRE W/O FILIF 90
Type of DeviceDISLODGER, STONE, BASKET
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-can[?]da, 24206
FR 24206
Manufacturer Contact
christine buckvold
MDR Report Key6390959
MDR Text Key69485291
Report Number9610711-2017-00009
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
PMA/PMN Number
K900269
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial
Report Date 03/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDOR4241002
Device Catalogue NumberDOR4241002
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/09/2017 Patient Sequence Number: 1
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