MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UNIDRIVE GYN MOTOR SYSTEM; GYN MORCELLATOR

Model Number 26711101-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cancer (3262)

Event Date 11/01/2011

Event Type  Injury  

Manufacturer Narrative

There was no indication of any malfunction of the device.The product has not been returned, therefore no evaluation has been completed.

Event Description

Allegedly, an electric morcellator was used during a laparoscopic hysterectomy procedure in 2011.The patient in 2013 subsequently developed sharp abdominal pain.In 2014 the patient underwent surgery to remove multiple leiomyomas in her abdomen.Additionally in 2014 health (b)(6) issued concerns of unsuspected uterine malignancies associated with the use of electric morcellators.In 2015 health (b)(6) issued a recall of karl storz morcellators.In 2019 the patient was found to have multiple lesions in the pelvic region and liver.In 2020 the patient underwent surgery for debulking the masses and a liver resection.

• Brand Name: UNIDRIVE GYN MOTOR SYSTEM
• Type of Device: GYN MORCELLATOR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo
• MDR Report Key: 14525366
• MDR Text Key: 293258897
• Report Number: 9610617-2022-00079
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K010346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26711101-1
• Device Catalogue Number: 26711101-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Sex: Female