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

Model Number 8424141

Device Problems Arcing of Electrodes (2289); Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2015

Event Type  malfunction  

Manufacturer Narrative

Rw (b)(4) recently received device and investigation is currently inprocess.Rw (b)(4) considers this report open and follow-up report to be sent at a later time.

Event Description

Facility reported that a device arched and damaged the tip of a second device being used during the procedure.The two impacted devices were swapped out to back up devices, readily available for use, and procedure was completed as scheduled.No injury to patient or staff reported.At least six devices are assembled together in order to be operated.The two devices which had product problems and their associated mdr's are: sheath (8661.3741) - mdr9611102-2015-00004 (tip damaged); electrode (8424.141) - mdr9611102-2015-00005 (device arched).

Manufacturer Narrative

This a follow-up in order to correct previous mdr.The device in question was used in conjunction with medical device reported in mdr 9611102-2015-00004.Previous report was sent as a manufacturer of device.Reporter is neither an importer or manufacter of device referenced in mdr 9611102-2015-00005.

Event Description

This a follow-up in order to correct previous mdr.The device in question was used in conjunction with medical device reported in mdr 9611102-2015-00004.Previous report was sent as a manufacturer of device.Reporter is neither an importer or manufacturer of device referenced in mdr 9611102-2015-00005.

• Brand Name: CUTTING ELECTRODE
• 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 GMBH; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; 32 pforzheimer street; knittlingen, 75438 ; GM 75438 ; 043351013
• MDR Report Key: 5186423
• MDR Text Key: 30282065
• Report Number: 9611102-2015-00005
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8424141
• Device Catalogue Number: 8424141
• Device Lot Number: 51003398
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2015
• Initial Date FDA Received: 10/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1