MAUDE Adverse Event Report: ADVANCED SURGICAL CONCEPTS LTD PNEUMOLINER; LAPAROSCOPIC POWER MORCELLATION CONTAINMENT SYSTEM

Model Number WA90500US

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

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

Event Date 10/10/2023

Event Type  Injury  

Event Description

Mw5146964 was received on 11.15.2023.The report states the following: "olympus gardenia uterine morcellation system bag ripped during morcellation process.No injury to underlying bowel or other organs.".

Manufacturer Narrative

Mw5146964 detailed insufficient and contradictory information which did not allow identification of the device or what, if any, injury occurred.The suspect device description and pro-code did not match.Furthermore, the physician name and institution is not provided which prevented investigation.Should new information become available a follow-up medwatch report will be submitted.

• 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): UFP TECHNOLOGIES LTD.; 300 burnett road; chicopee MA 01020
• Manufacturer Contact: edward hyland ; unit 1&4, sunnybank center; upper dargle road; bray, co. wicklow A98 E-339 ; EI A98 E339
• MDR Report Key: 18291170
• MDR Text Key: 330047230
• Report Number: 9616720-2023-00001
• Device Sequence Number: 1
• Product Code: PMU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192898
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WA90500US
• Device Catalogue Number: WA90500US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• 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
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White