MAUDE Adverse Event Report: RICHARD WOLF GMBH CUTTING ELECTRODE, STERILE

Model Number 4653.1313

Device Problems Break (1069); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2016

Event Type  malfunction  

Manufacturer Narrative

Unable to perform investigation as actual device has not been received by (b)(4) as of 10/18/2016.User facility has been contacted in an effort to have device, or photos of device, returned for investigation.No response as of 10/18/2016.No similar issues have been reported to (b)(4) on this device in the last three years.This report is considered closed.However, in the event (b)(4) receives additional information it will be forwarded onto rw(b)(4) (manufacturer).Rw(b)(4) will supply follow up reports, when needed.(b)(4).Device not returned.

Event Description

(b)(4) received a copy of a voluntary medwatch report ((b)(4)) from the fda on 09/27/2016.Report indicated that during a hysteroscopic polyp resection, the device in question sparked.Resectoscope containing the electrode was removed and doctor noticed the electrode was broken.Electrode was removed and replaced with a rollerball device in order to complete procedure.No injury to patient or doctor was reported.

• Brand Name: CUTTING ELECTRODE, STERILE
• Type of Device: ELECTRODE
• Manufacturer (Section D): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; registration #9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; reg #9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438 ; 043351013
• MDR Report Key: 6036920
• MDR Text Key: 57737896
• Report Number: 9611102-2016-00008
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/18/2016,09/27/2016

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: Physician
• Device Expiration Date: 02/01/2020
• Device Model Number: 4653.1313
• Device Lot Number: 4500161523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2016
• Distributor Facility Aware Date: 09/27/2016
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2016
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• 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
• Treatment: CABLE; RESECTOSCOPE
• Patient Age: 72 YR
• Patient Weight: 70