MAUDE Adverse Event Report: ADVANCED SURGICAL CONCEPTS LTD PNEUMOLINER; LAPAROSCOPIC POWER MORCELLATION CONTAINMENT SYSTEM

Model Number WA90500US

Device Problems Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2017

Event Type  malfunction  

Manufacturer Narrative

Based on discussion with the clinical specialist (cs) as part of asc's investigation into this event, the company understands that the trocars were not removed and the surgeon used a zero degree endoscope.Trocar removal and endoscope requirement is covered in physician training and is addressed in the ifu.Based on the company's investigation, this event appears to be due to user error.Although it is unclear whether such a malfunction would be likely to cause or contribute to a death or serious injury if it were to recur, asc is filing this mdr out of an abundance of caution to ensure full compliance with 21 cfr part 803.

Event Description

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 using a zero degree endoscope.The pl ifu and training clearly state a minimum of a 30-degree scope is required to perform a contained morcellation.The surgeon said he was well into the morcellation when there was a failure.It is unclear what caused the tear in the pl.The tear in the pl was propagated when the surgeon attempted to remove it with excess tissue still remaining to be morcellated.The device was returned to the distributor for evaluation.The inspection clearly identified the hole that was made by the surgeon.The company believes the information provided by the cs and the inspection of the returned device is sufficient to evaluate the complaint.

• Brand Name: PNEUMOLINER
• Type of Device: LAPAROSCOPIC POWER MORCELLATION CONTAINMENT SYSTEM
• Manufacturer (Section D): ADVANCED SURGICAL CONCEPTS LTD; unit 4, sunnybank center; upper dargle road; bray, county wicklow A98 E 339; EI A98 E339
• Manufacturer (Section G): DIELECTRICS INC.; 300 burnett road; chicopee MA 01020
• Manufacturer Contact: edward hyland ; unit 4, sunnybank center; upper dargle road; bray, county wicklow A98 E-339 ; EI A98 E339
• MDR Report Key: 7497699
• MDR Text Key: 108251839
• Report Number: 9616720-2017-00001
• Device Sequence Number: 1
• Product Code: PMU
• UDI-Device Identifier: 05391530440004
• UDI-Public: 010539153044000417190719999102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2017

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
• Device Operator: Physician
• Device Expiration Date: 07/19/2019
• Device Model Number: WA90500US
• Device Catalogue Number: WA90500US
• Device Lot Number: 999102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2016
• 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 Age: 46 YR
• Patient Weight: 88