MAUDE Adverse Event Report: ADVANCED SURGICAL CONCEPTS PNEUMOLINER CONTAINMENT DEVICE

Model Number WA90500US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Laceration(s) (1946)

Event Date 09/03/2021

Event Type  Injury  

Event Description

It was reported to olympus by the customer, pneumoliner containment device for laparoscopic morcellation with laparoscopic instrument port was used during a laparoscopic supracervical hysterectomy (lsh) , on a female patient.The user reported upon removal the pneumoliner containment device, the patient sustained a small abrasion/nick to the mesentery.The patient required three very small stitches to minimize the risk of capturing a branching blood vessel and cutting off blood supply to the mesentery.The small bowel remained intact and did not require sutures.

Event Description

Update: additional/clarified patient/event information provided by the customer: when doctor deployed the bag in the customary way it appears the that the bag was packaged in the sleeve incorrectly in a way that when deployed the bag was inverted.When trying to remove the bag the folded tail of the bag trapped a loop of small bowel.The surgeon realized that the small bowel loop was caught up inside the bag and was able to stop extracting the bag and to carefully release the loop of small bowel.Upon conclusion of the morcellation the bag was withdrawn and noted to be intact.The small bowel was then carefully inspected and was noted to have a mesentery injury (laceration) from being caught up in the bag.This was repaired with suture and the patient was sent to recovery room in good condition.The patient had a normal post-operative course with no complications.

• Brand Name: PNEUMOLINER CONTAINMENT DEVICE
• Type of Device: PNEUMOLINER CONTAINMENT DEVICE
• Manufacturer (Section D): ADVANCED SURGICAL CONCEPTS; upper dargle road; bray, wicklow BRAY ; EI BRAY
• MDR Report Key: 12554789
• MDR Text Key: 274063236
• Report Number: 2951238-2021-00419
• Device Sequence Number: 1
• Product Code: PMU
• UDI-Device Identifier: 05391530440004
• UDI-Public: 05391530440004
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 09/07/2021,10/19/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: WA90500US
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 61