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 Codes	Inability to Irrigate (1337); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
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.B3: estimated date.
Event or Problem Description
According to the available information the device does not work.
Event or Problem Description
According to the available information the device does not work.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we find none regarding the lot number.This lot is part of a foreign field safety notice initiated in august 2025.The investigation showed that the bitubes inside the handle were collapsed.This collapsing doesn't allow suction or irrigation, so the elefant is non-functional.A corrective and preventive action was opened in august 2025 to manage this issue.The root cause has been identified: the ring protector around the handle was not correctly placed on the elefant buttons, and the actions are ongoing.A clinical assessment was performed and concludes: the malfunction of the elefant suction¿irrigation device, caused by a misplaced handle protection cap, results in a complete loss of suction and irrigation functionality.As stated in the instructions for use, the device must be tested before use, which allows early identification of the issue and prevents patient contact.In most cases, the clinical impact is limited to a prolonged procedure and device replacement, corresponding to a severity level 2 risk.However, given that the entire lot appears to be affected, it cannot be ruled out that a replacement device will be available in the unit, which may result in procedure rescheduling, increasing the clinical impact to severity level 3.No sterility concerns are identified, as the device tip remains properly sterilized and isolated from internal fluid pathways.In addition, this product was used by an hospital not identified for this lot in the fsca communication, due to an error during the order preparation.The operator reversed 2 orders of 2 hospital of the same reference but different lot numbers.This issue was covered by a non-conformity.

• 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: 23167909
• Report Number: 9610711-2025-00425
• Device Sequence Number: 8845001
• Product Code: FQH
• UDI-Device Identifier: 03600040970676
• UDI-Public: 3600040970676
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/04/2026

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: 10403531_ASP1654002
• 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: 09/29/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2025
• 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