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

Model Number WA90500US

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

Sus voluntary event report (# mw5091187) was filed in the medsun database (fda maude).

Event Description

The pneumoliner bag had been damaged during surgery by grasping the tissue specimen and the bag and engaging the power morcellator.The surgical technician noticed and the procedure was stopped.The surgeon confirmed there was no viscera damage and it was only the pneumoliner bag that had been breached.Some pieces of the fibroid tissue spilled into the abdominal cavity.These were picked out; no fragments were left in the patient.The surgical technician noticed a small piece of the bag was missing.The surgical team did everything they could to locate the small piece of bag material.They flushed the abdominal cavity with 2l of saline.They flushed saline through the lena morcellator and they examined the morcellated tissue but were unable to locate the missing piece of the bag.They also performed an x-ray on the patient as this was hospital protocol.This report is being raised as a patient injury due to the unknown location of the specimen bag fragment and the possibility that it remained in the patient.Although it is unlikely whether such an event resulting in a small piece of polyurethane material, would be likely to cause or contribute to a death or serious injury if it were to recur, asc is filing this medwatch report out of an abundance of caution to ensure full compliance with 21 cfr part 803.The pathology report shows the patient was cancer free.There was no injury to the patient from use of the device.The patient reported no adverse reaction.

• Brand Name: PNEUMOLINER
• Type of Device: LAPAROSCOPIC POWER MORCELLATION CONTAINMENT SYSTEM
• Manufacturer (Section D): ADVANCED SURGICAL CONCEPTS LTD.; unit 1&4, sunnybank center; upper dargle road; bray, A98 E 339; EI A98 E339
• Manufacturer (Section G): DIELECTRICS INC.; 300 burnett road; chicopee MA 01020
• Manufacturer Contact: edward hyland ; unit 1&4, sunnybank center; upper dargle road; bray, co. wicklow A98 E-339 ; EI A98 E339
• MDR Report Key: 9564294
• MDR Text Key: 174148912
• Report Number: 9616720-2019-00002
• Device Sequence Number: 1
• Product Code: PMU
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/02/2020
• Device Model Number: WA90500US
• Device Catalogue Number: WA90500US
• Device Lot Number: 113202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization
• Patient Age: 48 YR