MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) 22 FR CUTTING LOOP, STERILE; ELECTRODE

Model Number 46221313

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Electric Shock (2554)

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

System consists of the following devices: inner sheaths, working element, bipolar cable, electrode, generator, powercable, footswitch, endoscope, outer sheath, rotatable connector.The inner sheath, working element and bipolar cable were returned for investigation.No issues were found with the three device returned for investigation., therefore the most likely suspect device was the electrode.The suspect device was discarded by user facility and not available for investigation.Two possibles which may have lead to doctor getting shocked: electrode may have been damaged, inadvertent activation of footswitch while holding instrument system.No similar issues on this device on the last three years.Labeling was reviewed and found to be adequate.Ie intended use, indications, combinations, reprocessing "disposable" devices, cautions and warnings of the dangers of electric shock.Rwmic considers this matter closed.However, in the event we receive additional information, we will provide fda with follow-up information.Discarded by user facility.

Event Description

Facility called richard wolf medical instruments corporation (rwmic) and report that during a case the doctor picked up instrument system and was shocked.No injury to patient or any other staff reported.System consists of the following devices: inner sheaths, working element, bipolar cable, electrode, generator, powercable, footswitch, endoscope, outer sheath, rotatable connector.Only inner sheaths, working element & bipolar cable were submitted for investigation.

• Brand Name: 22 FR CUTTING LOOP, STERILE
• Type of Device: ELECTRODE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); 353 corportate woods parkway; vernon hills IL 60061 3110
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); 353 corportate woods parkway; vernon hills IL 60061 3110
• Manufacturer Contact: dawn clark ; 353 corportate woods parkway; vernon hills, IL 60061-3110 ; 8003239653
• MDR Report Key: 5237714
• MDR Text Key: 31975957
• Report Number: 1418479-2015-00040
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 46221313
• Device Catalogue Number: 46221313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 35 YR
• Patient Weight: 66