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

Model Number	DOR4241002
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Damage (2104); No Code Available (3191)
Date of Event	03/05/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: DRM 4 HL WIRE W/O FILIF 90
• Common Device Name: DISLODGER, STONE, BASKET
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 6390959
• Report Number: 9610711-2017-00009
• Device Sequence Number: 565647
• Product Code: FFL
• UDI-Device Identifier: 03600040227497
• UDI-Public: 03600040227497
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K900269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2017

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?: Yes
• Operator of Device: Physician
• Device Model Number: DOR4241002
• Device Catalogue Number: DOR4241002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2017
• Initial Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR