MAUDE Adverse Event Report: ADVANCED SURGICAL CONCEPTS PNEUMOLINER CONTAINMENT DEVICE

Model Number	WA90500US
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: PNEUMOLINER
• Manufacturer (Section D): ADVANCED SURGICAL CONCEPTS; upper dargle road; bray, bray A98 ; EI A98
• MDR Report Key: 18221901
• Report Number: 2429304-2023-00366
• Device Sequence Number: 6748199
• Product Code: PMU
• UDI-Device Identifier: 05391530440004
• UDI-Public: 05391530440004
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2023
• Report Date (Section F): 10/31/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown