MAUDE Adverse Event Report: ADVANCED SURGICAL CONCEPTS PNEUMOLINER CONTAINMENT DEVICE

Model Number WA90500US

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2023

Event Type  Injury  

Event Description

A medwatch report was received reporting the system bag of pneumoliner containment device for laparoscopic morcellation with laparoscopic instrument port ripped during morcellation process.The medwatch notes that the patient was hospitalized but no details were able to be obtained due to lack of contact information.It was noted that no injury to underlying bowel or other organs occurred.

• Brand Name: PNEUMOLINER CONTAINMENT DEVICE
• Type of Device: PNEUMOLINER
• Manufacturer (Section D): ADVANCED SURGICAL CONCEPTS; upper dargle road; bray, bray A98 ; EI A98
• MDR Report Key: 18221901
• MDR Text Key: 329192471
• Report Number: 2429304-2023-00366
• Device Sequence Number: 1
• Product Code: PMU
• UDI-Device Identifier: 05391530440004
• UDI-Public: 05391530440004
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2023,11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• 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(MEDWATCH)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization