MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS GARDENIA FIBROID MORCELLATION SYSTEM; CONTAINMENT SYSTEM, LAPAROSCOPIC POWER MORCELLATION, WITH INSTRUMENT PORT

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

Event Date 10/10/2023

Event Type  Injury  

Event Description

Olympus gardenia uterine morcellation system bag ripped during morcellation process.No injury to underlying bowel or other organs.

• Brand Name: OLYMPUS GARDENIA FIBROID MORCELLATION SYSTEM
• Type of Device: CONTAINMENT SYSTEM, LAPAROSCOPIC POWER MORCELLATION, WITH INSTRUMENT PORT
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH
• MDR Report Key: 17940259
• MDR Text Key: 325834646
• Report Number: MW5146964
• Device Sequence Number: 1
• Product Code: PMU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White