Elefant ASP185Recalls & reported problems
Coloplast A/S · Class 2
Quick summary
This Coloplast Elefant jet lavage device flushes and suctions fluid during procedures. Reports most often describe suction stopping or the device being unable to irrigate, and some mention a cannula breaking inside the patient's abdomen during surgery. There are 260 reports, with no deaths and no injuries. Reports dropped to 6 in the last 12 months from 254 in the year before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 260
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 260 adverse event reports that list this exact device (DI 03600040970799), received between Jul 23, 2025 and Mar 5, 2026 — classified as 260 malfunctions.
The most frequently reported specific device problem is “Suction Failure” (256 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Suction Failure256
- Inability to Irrigate244
- Suction Problem3
- Device Misassembled During Manufacturing /Shipping2
- Complete Blockage1
- Material Separation1
- Missing Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions259
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 260 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE MEDICAL TEAMS NOTICED THAT A SUCTION DEVICE WAS NOT WORKING. THEY CHECKED THAT THEIR SUCTION SYSTEM WAS WORKING PROPERLY BY DISCONNECTING IT, WHICH WAS INDEED THE CASE. AFTER CHECKING SEVERAL UNITS FROM THIS LOT, THEY FOUND THAT NONE OF THEM WERE WORKING. HOWEVER, UNITS FROM A DIFFERENT LOT WERE WORKING NORMALLY. THREE DEFECTIVE SUCTION DEVICES CURRENTLY ARE IN QUARANTINE. THEY ARE CURRENTLY USING SUCTION DEVICES FROM DIFFERENT LOTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518871 ↗MalfunctionMar 5, 2026Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE MEDICAL TEAMS NOTICED THAT A SUCTION DEVICE WAS NOT WORKING. THEY CHECKED THAT THEIR SUCTION SYSTEM WAS WORKING PROPERLY BY DISCONNECTING IT, WHICH WAS INDEED THE CASE. AFTER CHECKING SEVERAL UNITS FROM THIS LOT, THEY FOUND THAT NONE OF THEM WERE WORKING. HOWEVER, UNITS FROM A DIFFERENT LOT WERE WORKING NORMALLY. THREE DEFECTIVE SUCTION DEVICES CURRENTLY ARE IN QUARANTINE. THEY ARE CURRENTLY USING SUCTION DEVICES FROM DIFFERENT LOTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518869 ↗MalfunctionMar 5, 2026Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE MEDICAL TEAMS NOTICED THAT A SUCTION DEVICE WAS NOT WORKING. THEY CHECKED THAT THEIR SUCTION SYSTEM WAS WORKING PROPERLY BY DISCONNECTING IT, WHICH WAS INDEED THE CASE. AFTER CHECKING SEVERAL UNITS FROM THIS LOT, THEY FOUND THAT NONE OF THEM WERE WORKING. HOWEVER, UNITS FROM A DIFFERENT LOT WERE WORKING NORMALLY. THREE DEFECTIVE SUCTION DEVICES CURRENTLY ARE IN QUARANTINE. THEY ARE CURRENTLY USING SUCTION DEVICES FROM DIFFERENT LOTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518868 ↗MalfunctionFeb 19, 2026Complete Blockage; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION SUCTION STOPPED ABRUPTLY, IMPOSSIBLE TO RELIEVE BLOCKAGE. IMPOSSIBLE TO SUCTION HEAVY BLEEDING DURING ROBOTIC LAPAROSCOPY. IMMEDIATE AND QUICK REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24389127 ↗MalfunctionDec 30, 2025Missing Information; Missing Information
ACCORDING TO THE AVAILABLE INFORMATION PRODUCT WAS DELIVERED WITHOUT PRODUCT STICKERS/ IDENTIFICATION LABELS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927877 ↗MalfunctionDec 22, 2025Suction Failure; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE FAILED DURING ACTIVATION OF THE SUCTION. THE DEVICE WAS NOT USED AND WAS REPLACED WITH ANOTHER UNIT FROM THE SAME LOT, WHICH DID NOT SHOW ANY DEVIATION. NO PATIENT HARM HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23863590 ↗MalfunctionOct 20, 2025Material Separation; Material Separation
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.
Patient problems: Foreign Body In Patient
MAUDE report 23335888 ↗MalfunctionSep 23, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE TUBING FROM THE SAME BATCH DOES NOT SUCK. PROBLEM OCCURRED 3 TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23124113 ↗MalfunctionSep 23, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE TUBING FROM THE SAME BATCH DOES NOT SUCK. PROBLEM OCCURRED 3 TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23124107 ↗MalfunctionSep 23, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE TUBING FROM THE SAME BATCH DOES NOT SUCK. PROBLEM OCCURRED 3 TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23124104 ↗MalfunctionSep 23, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THERE WAS NO ASPIRATION ON THREE DEVICES FROM THE SAME LOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23122183 ↗MalfunctionSep 23, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THERE WAS NO ASPIRATION ON THREE DEVICES FROM THE SAME LOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23122182 ↗MalfunctionSep 23, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THERE WAS NO ASPIRATION ON THREE DEVICES FROM THE SAME LOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23122180 ↗MalfunctionSep 19, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE DOES NOT SUCK OR FLUSH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23096534 ↗MalfunctionSep 18, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE SUCTION AND IRRIGATION ARE NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084154 ↗MalfunctionSep 18, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE IS NOT WORKING WITH NO SUCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23083651 ↗MalfunctionSep 17, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THERE WAS NO POSSIBILITY OF SUCTION OR WASHING. SEVERAL DEVICES WERE OPENED AND HAD THE SAME PROBLEM/ A 35CM SUCTION WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23076599 ↗MalfunctionSep 17, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THERE WAS NO POSSIBILITY OF SUCTION OR WASHING. SEVERAL DEVICES WERE OPENED AND HAD THE SAME PROBLEM/ A 35CM SUCTION WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23076598 ↗MalfunctionSep 17, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THERE WAS NO POSSIBILITY OF SUCTION OR WASHING. SEVERAL DEVICES WERE OPENED AND HAD THE SAME PROBLEM/A 35 CM SUCTION WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23076576 ↗MalfunctionSep 17, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE IS NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23074715 ↗MalfunctionSep 17, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE IS NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23074575 ↗MalfunctionSep 17, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE IS NOT WORKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23074519 ↗MalfunctionSep 17, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION DURING A COLOSCOPY INTERVENTION, THE DEVICE DID NOT WORK. THE WASHING AND SUCTION DID NOT FUNCTION WHEN USERS PRESSED THE BUTTONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23074335 ↗MalfunctionSep 17, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS UNABLE TO BE USED AND SUCTION IN THE PATIENT'S ABDOMEN AT THE BEGINNING OF THE SURGICAL PROCEDURE. CHANGE OF SUCTION DEVICE AND THE SAME PROBLEM WAS ENCOUNTERED. A THIRD DEVICE FROM A DIFFERENT LOT NUMBER WAS USED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23074279 ↗MalfunctionSep 17, 2025Inability to Irrigate; Suction Failure; Inability to Irrigate; Suction Failure
ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WAS UNABLE TO BE USED AND SUCTION IN THE PATIENT'S ABDOMEN AT THE BEGINNING OF THE SURGICAL PROCEDURE. CHANGE OF SUCTION DEVICE AND THE SAME PROBLEM WAS ENCOUNTERED. A THIRD DEVICE FROM A DIFFERENT LOT NUMBER WAS USED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23074278 ↗
Other LAVAGE, JET devices
- PULSAVAC® 00-5150-475-01Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET255 reports
- PULSAVAC® 00-5150-482-00Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET197 reports
- PULSAVAC® 00-5150-475-00Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET164 reports
- Versajet 66800039Smith & Nephew Medical Limited · Lavage, Jet160 reports
- PULSAVAC® 00-5150-482-01Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET154 reports
- Surgiphor 910110Carefusion 2200, Inc · LAVAGE, JET140 reports
- Axius Blower/Mister CB-1000Maquet Cardiovascular LLC · Lavage, Jet1 recall43 reports
- Versajet 66800041Smith & Nephew Medical Limited · Lavage, Jet78 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.