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

Model Number	AXXL101002
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, the slit in the side of the device did not appear flush with the shaft.The surgeon felt that it could be traumatizing to the ureter and did not want to use it.A new device was opened and the case was completed without issue.
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 information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.
Event or Problem Description
According to the available information, the slit in the side of the device did not appear flush with the shaft.The surgeon felt that it could be traumatizing to the ureter and did not want to use it.A new device was opened and the case was completed without issue.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and didn't find another complaints regarding the lot number 8638692.Checking the quality databases did not reveal any anomaly in relation to the described defect.Without a sample we cannot do more than documentary investigation which revealed no anomaly during production.According to the documentation process we note that orange sheath was controlled by our quality laboratory which revealed product conformed.At the end of the manufacturing process each axxl101002 was assembled and controlled at 100%: no difficulty or blockage must be observed.For this complaint the risk evaluation has been done based on the risk criteria from the procedure for risk management reference (b)(4) , doc no.(b)(4) version 5.0.The evaluation has shown that risks are adequately controlled and reduced as far as possible in the state of art.Based on this, we can conclude that residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.It is concluded that the risks identified are still acceptable and considered as safe.

• Brand Name: RETRACE URETERAL ACCESS SHEATH
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16857535
• Report Number: 9610711-2023-00069
• Device Sequence Number: 18299401
• Product Code: FED
• UDI-Device Identifier: 03600040277508
• UDI-Public: 03600040277508
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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: Health Professional
• Device Model Number: AXXL101002
• Device Catalogue Number: AXXL10
• Device Lot Number: 8638692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown