MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS (RWMIC) MONOPOLAR CUTTING ELECTRODE

Model Number 8424.1310

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

A full investigation not be completed, as the actual device was not returned to the richard wolf facility.Device purchased date - thirteen different lots were purchased by user facility from feb 2015 to nov 2016.No similar complaint have occurred in the last three years on this device.Instruction for use statement: 7 use caution! the products have only limited strength! excessive force will cause damage, impair the function and therefore endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Make sure that no missing parts remain in the patient.Do not use the products if they are damaged or incomplete or have loose parts.Richard wolf considers this matter closed.However, in the event the device is returned or additional information is received, rwmic will provide fda with a follow-up report.

Event Description

Facility reported to richard wolf medical instruments corporation (rwmic) that during a prostate resection the loop of an electrode fell off and was left in the patient.Ten months after procedure, patient had foreign removed at a different facility.Facility contacted via email for missing/additional information regarding this event.Facility responded and information received entered into this report.

• Brand Name: MONOPOLAR CUTTING ELECTRODE
• Type of Device: ELECTRODE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS (RWMIC); 353 corporate woods parkway; vernon hills IL 60061 3110
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS (RWMIC); 353 corporate woods parkway; vernon hills IL 60061 3110
• Manufacturer Contact: dawn clark ; 353 corprate woods parkway; vernon hills, IL 60061 ; 8003239653
• MDR Report Key: 7050423
• MDR Text Key: 93450450
• Report Number: 1418479-2017-00032
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8424.1310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/21/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 80