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 Bowel Perforation (2668)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A zero-degree scope was used for vision inside the bag contrary to the validated training and ifu which states a minimum of 30 degree scope is required to give an adequate field of vision.An untrained resident was actuating the tenaculum.The training and ifu stipulates that only a physician who has completed the validated pneumoliner training may perform the contained morcellation procedure.

Event Description

While performing the contained power morcellation the pneumoliner bag was punctured and a section of small bowel was morcellated.The physician grasped the pneumoliner bag with the tenaculum and proceeded to engage the power morcellator and morcellated a section of the pneumoliner bag and a section of small bowel.The patient underwent end to end anastomosis with approximately 20 cm of bowel resected.The patient has left hospital after a return to normal bowel function.

• 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, county wicklow A98 E-339 ; EI A98 E339
• MDR Report Key: 8771649
• MDR Text Key: 150414194
• Report Number: 9616720-2019-00001
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• 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: 06/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention