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 08/29/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.Based on asc's investigation of this event to date, which included discussions with the clinical specialist in attendance at the case and the surgeon, asc believes that this event was the result of user error.Because it is unclear whether or the extent to which the pneumoliner caused or contributed to this event, asc is submitting this mdr out of an abundance of caution to ensure full compliance with 21 cfr part 803.

Event Description

On (b)(6) 2017, asc became aware of the following event involving the pneumoliner (pl).The procedure was a supracervical hysterectomy.It was reported that the surgeon was attempting to grab soft tissue at the base of the pl and inadvertently grabbed the pl and the small bowel as well, with the tenaculum.The surgeon said the pl performed as intended, unrolling and inflating and providing a large space for morcellation.There was a large calcified fibroid which she found very hard to morcellate.The surgeon grabbed the side of the pl along with the tissue, which she noticed when drawing the tissue towards the morcellator.The surgeon could see a 5mm tear in the pl and a loop of small bowel pushing into the pl.The surgeon marked the section of bowel that was damaged, closed off the tear in the pl with a kelly clamp and hand-morcellated the remaining fibroid at the incision site.A general surgeon then made the repair to the section of the bowel that was damaged during the same surgery.The surgeon stated the patient had made a full recovery.

• 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: 7497700
• MDR Text Key: 107687869
• Report Number: 9616720-2017-00002
• 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: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: WA90500US
• Device Catalogue Number: WA90500US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2017
• Initial Date FDA Received: 05/09/2018
• 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): Required Intervention
• Patient Age: 49 YR