MAUDE Adverse Event Report: MORCELLATOR; HYSTEROSCOPE (AND ACCESSORIES)

Device Problem Use of Device Problem (1670)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Cancer (3262)

Event Date 04/01/2016

Event Type  Injury  

Event Description

Reporter called to report an adverse event after a surgical procedure where, a laparoscopic morcellator was used during a hysterectomy.Reporter described how, eight months prior to this event, she experienced heavy vaginal bleeding (no prior history) and that on three separate occasions, biopsy results were all negative for cancer cells.Reporter underwent a total hysterectomy and the excised tissue was sent to pathology which subsequently showed no evidence of cancer.Reporter had post-surgical complications and four to five weeks post-surgery, she continued to bleed heavily.Around this time, reporter said she found out that she did have cancer of the uterus.She underwent a second procedure and was found to have a ruptured hematoma where her uterus once was.Reporter was hospitalized for five days.Reporter states that the hematoma was a result of the morcellator from the first procedure and that the cancer was missed due to the morcellator's tissue dissections.Reporter continues to have medical problems.

• Brand Name: MORCELLATOR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• MDR Report Key: 17240000
• MDR Text Key: 318283252
• Report Number: MW5119026
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female