MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. ROTOCUT; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Device Problem Insufficient Information (3190)

Patient Problem Cancer (3262)

Event Date 03/28/2014

Event Type  Injury  

Event Description

In late (b)(6) 2013, a (b)(6) female consulted a gynecologist for management of symptomatic fibroids and menorrhagia.The patient had a known history of multiple fibroids and several episodes of intermittent, heavy, prolonged bleeding.A prior d&c did not identify any intracavitary pathology, and the endometrial sampling biopsy was benign.The surgeon recommended a total laparoscopic hysterectomy.During the informed consent procedure, the patient was informed about nature of fibroids and the low risk of malignancy.She was offered surgical and non-surgical options, and the risks of surgery were explained.In (b)(6) 2013, the patient underwent a total laparoscopic hysterectomy.The uterine specimen was too large to be removed through the vagina and a 15 mm storz morcellator was introduced through an abdominal port to reduce the size of the specimen.After the uterus had been reduced in size, the remaining uterine tissue was removed through the vagina.All pieces of the fibroid uterus were sent to pathology for examination and diagnosis.Nine days later, pathological examination of the uterine tissue identified an intermediate grade epithelioid leiomyosarcoma.The following day, the surgeon contacted the patient to inform her of the diagnosis and referred her to gyn oncology.In early (b)(6), the patient underwent a laparoscopic bilateral salpingo-oophorectomy, lysis of adhesions, and resection of an anterior abdominal wall mass.The pathologic examination of all tissue from this procedure, including the pelvic washings, was benign.The anterior wall mass was a benign leiomyoma.Post-operatively, the patient was followed in another institution's sarcoma clinic.Two subsequent cts the same year did not show any metastatic disease.In (b)(6) 2014, a follow-up surveillance ct scan showed multiple tumors on the serosa of the small bowel, consistent with recurrent and metastatic leiomyosarcoma.In late (b)(6) 2014, our hospital issued a new policy banning intraperitoneal power morcellation of uterine tumors outside of a containment system.This decision was based upon growing concerns that intra-peritoneal power morcellation of an occult leiomyosarcoma outside of a containment system could spread tumor around the peritoneal cavity, resulting in the upstaging of the tumor and a worsening of the patient's prognosis.Immediately after the fda's safety communication of april 17, 2014, the hospital immediately suspended the use of power morcellation for all gynecological procedures.

• Brand Name: ROTOCUT
• Type of Device: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 5443647
• MDR Text Key: 38427595
• Report Number: 5443647
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR