MAUDE Adverse Event Report: COLOPLAST A/S ACCESS SHEATH CH10-12 45; URETHRAL ACCESS SHEATH

Model Number	AXXL101002
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
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, during the extraction of a stone of less than 2 mm with dormia, they noticed that the access sheath cracks and that pieces of plastic remove at the same time.Several plastic wires are then recovered which have been flushed towards the kidney.Consequences: obligation of withdrawal of the plastic wires.Extension of the surgical time with skeptical risk if forgetful of filaments despite careful control with the ureteroscope.

• Brand Name: ACCESS SHEATH CH10-12 45
• Common Device Name: URETHRAL ACCESS SHEATH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 6360853
• Report Number: 9610711-2017-00006
• Device Sequence Number: 11069103
• Product Code: FED
• UDI-Device Identifier: 03600040277508
• UDI-Public: 03600040277508
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2017

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
• Operator of Device: Physician
• Device Model Number: AXXL101002
• Device Catalogue Number: AXXL101002
• Device Lot Number: 5246598
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 02/27/2017
• 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