MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-02-14 for MOTOR POWER PLUS CONTROL UNIT 2307101 manufactured by Richard Wolf Gmbh.
[136191623]
Device labeling was reviewed for patient code and device codes: relative or absolute contraindications may result from the general medical findings or in special cases in which the patient's risk for motor-driven tools is significantly increased. Ovaries, fallopian tubes, myomata and other structures must be devascularized and dissected before morcellation. The morcellator may not be used for: treatment of malignant tumours, treatment of vascularized tissue, preparation of tissue. Cases described in the relevant literature must be taken into account. As a matter of principle: the morce power plus may only be operated by competent trained personnel! The physician should read this entire manual with particular attention to the warnings, cautions and precautions section and be thoroughly familiar with the use of the instrument prior to performing any clinical procedure! Procedures performed using the morce power plus, as with any endoscopic instrument require adequate knowledge, training and preparation on the part of the physician/surgeon! The use of third-party products is the responsibility of the operator! Repairs are to be carried out by authorised richard-wolf service technicians exclusively! Failure to carefully follow all applicable instructions may result in significant injury to the patient, physician, or attendants and have an adverse effect on the outcome of procedures performed! Improper use and repair of the device, as well as failure to comply with our instructions absolves us from any performance guarantee or other claims! The use of a tissue extraction bag is recommended for the morcellation of tissue suspected of being malignant and for tissue the surgeon may consider to be potentially harmful when disseminated in the body cavity. Rwmic considers this complaint and mdr closed. If any additional information is provided, rwmic will provide a follow-up report as required.
Patient Sequence No: 1, Text Type: N, H10
[136191624]
On (b)(6) 2016, richard wolf medical instruments corporation (rwmic) was notified by our attorney of a lawsuit filed on behalf of the deceased patient. The following information was provided: on (b)(6) 2012, the patient underwent a surgical procedure known as a laparoscopic supracervical hysterectomy and left salpingo-oophorectomy. During that procedure, the surgeon utilized the power morcellator device to shred or morcellate and remove the patient's uterus. After the surgery, a pathology report showed leiomyosarcoma in the morcellated tissue. It is alleged that the morcellation surgery seeded or upstaged the patient's cancer. The patient went through chemotherapy and radiation treatment, as well as additional surgery treatment. The patient died on (b)(6) 2013. Labeling and design flaws are mentioned in the lawsuit and therefore, referenced in event problem and evaluation codes. The device listed was the morce power plus morcellator. Part and batch number information was not provided and the device was not returned for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2019-00006 |
| MDR Report Key | 8341082 |
| Report Source | OTHER |
| Date Received | 2019-02-14 |
| Date of Report | 2016-01-20 |
| Date of Event | 2012-12-17 |
| Date Facility Aware | 2016-01-20 |
| Report Date | 2019-02-08 |
| Date Reported to FDA | 2019-02-08 |
| Date Reported to Mfgr | 2019-02-08 |
| Date Mfgr Received | 2019-02-08 |
| Date Added to Maude | 2019-02-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. OLIVER EHRLICH |
| Manufacturer Street | PFORZHEIMER STREET 32 |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal | 75438 |
| Manufacturer G1 | NOUVAG AG |
| Manufacturer Street | ST. GALLERSTRASSE 23-25 |
| Manufacturer City | GOLDACH, 9403 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 9403 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOTOR POWER PLUS CONTROL UNIT |
| Generic Name | MOTOR POWER PLUS CONTROL UNIT |
| Product Code | HET |
| Date Received | 2019-02-14 |
| Model Number | 2307101 |
| Catalog Number | 2307101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STREET 32 KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Life Threatening; 4. Required No Informationntervention | 2019-02-14 |