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

Model Number WA90500US

Device Problems Nonstandard Device (1420); Difficult to Open or Close (2921); Component Misassembled (4004)

Patient Problem Rupture (2208)

Event Date 09/03/2021

Event Type  Injury  

Event Description

The surgeon described the lsh and contained power morcellation procedure undertaken and the events that led to the patient injury; an abrasion of the mesentery requiring a couple of stitches and a minor serosal injury (a breach of integrity of the visceral peritoneum, the outermost covering of the bowel wall) that did not require any stitches.Upon deployment of the bag from the introducer the surgeon noted that the bag material was on top of the open mouth of the bag.Specifically, the bag deployed upside down.The bag should deploy with the bag material underneath the open mouth of the bag.The surgeon described that the bag material interfered with his encapsulation of the specimen/closure of the bag.He stated that the a loop of small bowel was between the bag material and the opening ring at the 6 o'clock position.This was not identified by the surgeon and the surgeon proceed to close the bag by pulling on the tether.This trapped/pinched the loop of bowel between the opening ring and the boot at the incision.This was immediately noted by the surgeon when he went to open the mouth of the bag.The loop of small bowel was released from the incision and the contained power morcellation was completed without further incident.The surgeon confirmed that the bag integrity was not compromised.Upon removal of the bag the surgeon reattached the quadport+ boot (used to perform the single port lsh) to check for hemostasis and undertook an examination of the bowel.He was able to do this externally through the incision and identified the section of small bowel and mesentery that had been momentarily trapped/pinched.The mesentery had some bright red bleeding that the surgeon repaired with a couple of stitches.No further intervention was required.The patient made a full recovery and left the hospital on the same day as the procedure.The surgeon has seen the patient twice with no sequalae.

• 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, co. wicklow A98 E 339; EI A98 E339
• Manufacturer (Section G): UFP TECHNOLOGIES; 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: 12468188
• MDR Text Key: 272885884
• Report Number: 9616720-2021-00001
• Device Sequence Number: 1
• Product Code: PMU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192898
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: WA90500US
• Device Catalogue Number: WA90500US
• Device Lot Number: 667060
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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): Death; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 66