MAUDE Adverse Event Report: Coloplast A/S Elefant suction-irrigation device; Surgical irrigation/aspiration cannula, non-illuminating, single-use

Catalog Number	ASP165
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.
Event or Problem Description
According to the available information while suction and water delivery were possible during use of the product, water delivery continued even when no button operations were performed on the device.
Event or Problem Description
According to the available information while suction and water delivery were possible during use of the product, water delivery continued even when no button operations were performed on the device.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we found one other complaint regarding the lot number on the same defect.On 8th january 2026, we received the incrimated sample.This samples was dirty, blood was all inside the tubes, according to our procedure we have decided to discard and not analyze the sample received.Our hungarian site investigated and concluded: "without a sample we can not make further investigation, only possible causes can be found: if the water flows through the device without operating the buttons, that means, the hammer inside the handle does not put enough pressure to the inner tubes.We have a 100% check for this failure in the production.We test every piece of elefant device on the pressure tester for this kind of failure.If the operator founds a defective product it is immediately discarded." checking the quality databases revealed no anomaly in connection with the described problem.

• Brand Name: Elefant suction-irrigation device
• Common Device Name: Surgical irrigation/aspiration cannula, non-illuminating, single-use
• Manufacturer (Section D): Coloplast A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-Sarlat; 9 avenue edmond rostand; sarlat la canéda cedex 24200 ; FR 24200
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 24056556
• Report Number: 9610711-2026-00022
• Device Sequence Number: 9421135
• Product Code: FQH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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 Catalogue Number: ASP165
• Device Lot Number: 10269165_ASP1654002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/08/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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
• Patient Sex: Unknown