MAUDE Adverse Event Report: COLOPLAST A/S RETRACE URETERAL ACCESS SHEATH; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number AXXL123002

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 the procedure, a 20-centimeter piece of material from the inside of the sheath (abrasion) came loose and had to be removed from the patient's kidney.The abrasion can be seen inside the sheath.The procedure was prolonged as a result.

Manufacturer Narrative

Visual examination of the returned product revealed a little tube with a wire inside.There was insufficient evidence that the issues observed were caused by a manufacturing issue.Based on images provided, it was believed the issue may have possibly been caused by a part or item being inserted into the product, which in turn may have caused the issue leading to a 20cm piece of material being removed from the part.

• Brand Name: RETRACE URETERAL ACCESS SHEATH
• Type of Device: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11726729
• MDR Text Key: 262711478
• Report Number: 3012649202-2021-00001
• Device Sequence Number: 1
• Product Code: FED
• Combination Product (y/n): N
• PMA/PMN Number: K181811
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AXXL123002
• Device Catalogue Number: AXXL12
• Device Lot Number: 7629149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention