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 Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information the cannula of the device broke during procedure.As reported by the physician the cannula broke inside the abdominal cavity of the patient.The doctor kept the broken cannula throughout the procedure and was able to complete it without needing a replacement of the device, because the device remained functional and without risk to the patient, even with the broken cannula.No harm to the patient was reported.
Additional Manufacturer Narrative
The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't found any other complaint on lot number.This component was tested at our quality laboratory and compliant with our specification.Without sample we cannot do more than documentary investigation which revealed no anomaly registered during manufacturing.According to the informations known quality database was checked and revealed no anomaly in relation to the describe defect.A similar case study was performed based on elefant product defect: damaged/broken over last four years, three similar cases were found a rmf evaluation was performed based on criq206 - risk identified 11311 (hazardous situation: elefant cannula breaks) 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.The harms, severity and occurrence are within anticipated levels per the risk documentation.It is concluded that the risks identified are still acceptable and considered as safe.
Event or Problem Description
According to the available information the cannula of the device broke during procedure.As reported by the physician the cannula broke inside the abdominal cavity of the patient.The doctor kept the broken cannula throughout the procedure and was able to complete it without needing a replacement of the device, because the device remained functional and without risk to the patient, even with the broken cannula.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; 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: 23335888
• Report Number: 9610711-2025-00449
• Device Sequence Number: 9451947
• Product Code: FQH
• UDI-Device Identifier: 03600040970799
• UDI-Public: 3600040970799
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: 10107808_ASP1854002
• Was Device Available for Evaluation?: No
• 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: 10/20/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2024
• 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