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

Catalog Number ASP185

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  Injury  

Event Description

According to the available information the cannula broke in two during the intervention.The entirety was able to be recovered.

• Brand Name: ELEFANT SUCTION-IRRIGATION DEVICE
• Type of Device: 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-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18539776
• MDR Text Key: 333194844
• Report Number: 9610711-2024-00021
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 03600040274125
• UDI-Public: 3600040274125
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASP185
• Device Lot Number: 9111502_ASP1851002
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 04/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other