MAUDE Adverse Event Report: COLOPLAST A/S ELEFANT SUCTION-IRRIGATION DEVICE; SURGICAL IRRIGATION/ASPIRATION CANNULA, NON-ILLUMINATING, SINGLE-USE

Catalog Number	ASP185
Medical Device Problem Codes	Fluid/Blood Leak (1250); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find any other complaints regarding the lot number 9260984.Checking quality database revealed no anomaly in connection with the described defect.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 the product didn't work properly, couldn't aspirate and was leaking.According to the report, the notifier identified a broken device without details.No harm to the patient was reported.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find others complaints regarding the lot number 9260984.Checking quality database revealed no anomaly in connection with the described defect our hungarian site performs its investigation and concludes: we have thoroughly reviewed the production documentation related to the reported product issue.Based on our internal records and quality checks, we did not identify any deviations or irregularities during the manufacturing process.Unfortunately, as we have not received a physical sample of the affected product, we are unable to conduct a more detailed investigation at this time.A rmf evaluation was performed based on criq206, risk identified 11405 (hazardous situation: no irrigation and/or suction).The evaluation has showed that risks are adequately controlled and reduced as far as possible in the state of art level.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.
Event or Problem Description
According to the available information the product didn't work properly, couldn't aspirate and was leaking.According to the report, the notifier identified a broken device without details.No harm to the patient was reported.

• 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
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 22977902
• Report Number: 9610711-2025-00288
• Device Sequence Number: 21189673
• Product Code: FQH
• UDI-Device Identifier: 03600040274125
• UDI-Public: 3600040274125
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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: ASP185
• Device Lot Number: 9260984_ASP1851002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2023
• 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