MAUDE Adverse Event Report: ETHICON INC. GYNECARE MORCELLEX UNKNOWN PRODUCT; LAPARSCOPE, GYNECOLOGIC

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

Patient Problems Surgical procedure (2357); Iatrogenic Source (2498); Treatment with medication(s) (2571)

Event Date 04/04/2013

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a laparoscopic surgical procedure to remove uterine fibroids on (b)(6) 2013 and the diva morcellex was utilized.It was reported that following the surgery, the patient was diagnoses with leiomyosarcoma, and has undergone aggressive treatment and therapy to treat the cancer.No additional information was provided.

Manufacturer Narrative

(b)(4).Conclusion: the device information for use under precautions states" caution: the use of a laparoscopic tissue extraction bag is recommended for the morcellation of malignant tissue or tissue suspected of being malignant and for tissue that the physician considers to be potentially harmful when disseminated in a body cavity.As morcellation may affect endometrial pathologic examination, preoperative evaluation of the endometrium should be considered.Should malignancy be identified, use of the gynecare morcellex¿ tissue morcellator may lead to dissemination of malignant tissue.

Manufacturer Narrative

It was reported that following the (b)(6) 2013 surgery, pathology reported the myometrium with a smooth muscle tumor of uncertain malignant potential.On (b)(6) 2014 she had a radical optimal tumor debulking, trachelectomy via laparotomy.Leiomyosarcoma was diagnoised on unk date and chemotherapy x6 on (b)(6) 2015.On (b)(6) 2015 she had a debulking of a pelvic mass.

• Brand Name: GYNECARE MORCELLEX UNKNOWN PRODUCT
• Type of Device: LAPARSCOPE, GYNECOLOGIC
• 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: 4720491
• MDR Text Key: 16309776
• Report Number: 2210968-2015-04873
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• 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: 01/29/2016
• 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: 61 YR
• Patient Weight: 57