PneumoLiner WA90500USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05391530440004), received between May 9, 2018 and Nov 28, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (DEN150028, K192898); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2023Break; Break

  A MEDWATCH REPORT WAS RECEIVED REPORTING THE SYSTEM BAG OF PNEUMOLINER CONTAINMENT DEVICE FOR LAPAROSCOPIC MORCELLATION WITH LAPAROSCOPIC INSTRUMENT PORT RIPPED DURING MORCELLATION PROCESS. THE MEDWATCH NOTES THAT THE PATIENT WAS HOSPITALIZED BUT NO DETAILS WERE ABLE TO BE OBTAINED DUE TO LACK OF CONTACT INFORMATION. IT WAS NOTED THAT NO INJURY TO UNDERLYING BOWEL OR OTHER ORGANS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18221901 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO OLYMPUS BY THE CUSTOMER, PNEUMOLINER CONTAINMENT DEVICE FOR LAPAROSCOPIC MORCELLATION WITH LAPAROSCOPIC INSTRUMENT PORT WAS USED DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY (LSH) , ON A FEMALE PATIENT. THE USER REPORTED UPON REMOVAL THE PNEUMOLINER CONTAINMENT DEVICE, THE PATIENT SUSTAINED A SMALL ABRASION/NICK TO THE MESENTERY. THE PATIENT REQUIRED THREE VERY SMALL STITCHES TO MINIMIZE THE RISK OF CAPTURING A BRANCHING BLOOD VESSEL AND CUTTING OFF BLOOD SUPPLY TO THE MESENTERY. THE SMALL BOWEL REMAINED INTACT AND DID NOT REQUIRE SUTURES.

  Patient problems: Abrasion; Laceration(s)

  MAUDE report 12554789 ↗
• MalfunctionMay 9, 2018Difficult or Delayed Positioning; Improper or Incorrect Procedure or Method; Difficult or Delayed Positioning; Improper or Incorrect Procedure or Method

  ON (B)(6) 2017, ASC RECEIVED A COMPLAINT THAT THE PNEUMOLINER (PL) CONTAINMENT DEVICE RIPPED OR CAME APART DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY. THE PHYSICIAN CONTINUED THE POWER MORCELLATION WITH THE RIPPED PL IN USE. THE CS INFORMED ASC THAT THE SURGEON DID NOT REMOVE THE TROCARS AS PER THE TRAINING PRIOR TO DEFLATION OF THE ABDOMEN. THEREFORE, THE PL DID NOT INFLATE FULLY. WARNING NUMBER 6 IN THE IFU STATES: "THE PNEUMOLINER MUST BE FULLY INFLATED (12 - 15MMHG) TO MINIMIZE THE RISK OF DAMAGE TO THE BAG AND ADJACENT ORGANS DURING MORCELLATION." THE CS NOTED A HOLE IN THE PL DURING THE CASE. THE SURGEON ATTEMPTED TO REMOVE THE PL BY PULLING ON THE PL WITH A LARGE AMOUNT OF FORCE. AS THERE WAS STILL TOO MUCH TISSUE REMAINING IN THE PL TO EXIT THE INCISION, THE TEAR/HOLE IN THE PL WAS PROPAGATED DUE TO THE LARGE FORCE EXERTED BY THE SURGEON. THIS RESULTED IN THE REMAINING CONTENTS OF THE PL SPILLING INTO THE PATIENT'S ABDOMEN AND THE PL EXITING THE INCISION. ASC SPOKE WITH SURGEON ON (B)(6) 2017. THE SURGEON INFORMED ASC HE HAD SOME DIFFICULTY GETTING THE PL TO UNROLL. HE STATED THERE WAS PLENTY OF SPACE TO MORCELLATE BUT HE WAS UNCERTAIN IF IT WAS FULLY DEPLOYED. HE WAS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7497699 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under DEN150028, K192898. One submission often covers many models, so check the product and lot details in each record.

• Z-0176-2022 · Sep 21, 2021 · Terminated
  ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimal