MAUDE Adverse Event Report: ETHICON INC. GYNECARE MORCELLEX UNKNOWN PRODUCT; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Death (1802); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357); Treatment with medication(s) (2571); Cancer (3262)

Event Date 09/26/2012

Event Type  Injury  

Event Description

It was reported that a patient underwent a robot-assisted hysterectomy with uterine morcellation in (b)(6) 2012.Prior to the surgery, there was no evidence of disseminated and/or metastatic cancer/disease.The patient was informed that she had cancer following the procedure.She has been undergoing aggressive treatment and therapy since the diagnosis was made.The patient has undergone advanced chemotherapy and radiation therapy.No additional information was provided.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a davinci stlh on (b)(6) 2012 with uterine morcellation.Prior to the surgery, there was no evidence of disseminated and/or metastatic cancer/disease.Pathological review of the specimen collected during the procedure showed significant atypia and pleomorphism with a diagnosis of leiomyosarcoma.The patient was started on 3 cycles of chemotherapy with gemcitabine taxotere d1 and underwent a hysterectomy and cervix removal on 2/5/2013.Mesenteric lesions were found on cat scan in (b)(6) 2013.The patient was prescribed 3 months of temador, and then underwent robotic exploration and an additional 3 cycles of chemotherapy with gemcitabine taxotere d1.

Manufacturer Narrative

Date sent to the fda: 01/13/2016.(b)(4).It was reported by an attorney that the patient underwent a robot-assisted supracervical laparoscopic hysterectomy on (b)(6) 2012, and a morcellator was utilized.The patient developed metastatic sarcoma in the sigmoid mesentery, and died of her disease in 2014.No additional information was provided.

• Brand Name: GYNECARE MORCELLEX UNKNOWN PRODUCT
• Type of Device: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): MEDTECH GROUP INC; 6 century ln; south plainfield NJ 07080
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3818913
• MDR Text Key: 4392455
• Report Number: 2210968-2014-06327
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• PMA/PMN Number: K100280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 68