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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device containment system, laparoscopic power morcellation, with instrument port
Definition Use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The device is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.
Product CodePMU
Regulation Number 884.4050
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED SURGICAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED SURGICAL CONCEPTS LTD.
  GRANTED 1
AGENCY FOR MEDICAL INNOVATIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2018 2 2
2019 2 2
2020 1 1
2021 2 2
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 4 4
Break 2 2
Difficult or Delayed Positioning 1 1
Nonstandard Device 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Component Missing 1 1
Difficult to Open or Close 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Bowel Perforation 2 2
No Known Impact Or Consequence To Patient 2 2
Device Embedded In Tissue or Plaque 1 1
No Code Available 1 1
Abrasion 1 1
Laceration(s) 1 1
Rupture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Oct-26-2021
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