MAUDE Adverse Event Report: RICHARD WOLF GMBH (GERMANY) MONOPOLAR CUTTING ELECTRODE, 21FR

Model Number	8353.131
Medical Device Problem Codes	Material Deformation (2976); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Rw (b)(4) is the manufacturer of this device.
Event or Problem Description
During hysteroresectoscopy of submucous node, at the third attempt of cutting disappeared the image on the screen.The operation was suspended, hysteroresectoscope derived from the cavity of the uterus: checked connection cables, light guide, light source, and camera - all in production mode; removed internal and external tubes - discovered damaged cutting electrode / loop / , which exploded and carbon deposits on hysteroresectoscope in place of the projection of the cutting electrode , which prevented the appearance of the image.To remove the cutting electrode was not possible because of the so-called "cleavage" at the distal end of the hysteroscope.Were used in the electrocoagulator of the firm "martin", mode cut g2 cut with "gain".Important information: the operation was repeated and the patient is in satisfactory condition.Richard wolf (b)(4) has not received a complaint.
Event or Problem Description
Follow up #1.
Additional Manufacturer Narrative
Follow up #1 the following sections updated/added: - product problem - suspect device - all manufacturers - device manufacturers.Device manufactured 27jul2015 and lot consists of (b)(4) units.Five electrodes were sold to facility on 18aug2015.The distal end of cutting electrode was not present.One side shows significant heat effects, resulting in a melted wire.The severe damage to the optics and the melted loop of the electrode suggest a high level of heat, probably caused by direct contact between the electrode loop and the scope during rf activation.On the one hand, in the case of proper use and combination of the products, it is structurally ensured that the electrode has no direct contact with the scope.On the other hand, it is pointed out in the instructions for use to activate the sling only in the field of vision and at a distance from conductive parts.It is therefore assumed that an application error.A product or manufacturing problem is not recognizable.Risk assessment, (b)(4), assessed with an acceptable risk.This rating is still valid considering the current case.Richard wolf (b)(4) considers this matter closed.However, in the event richard wolf (b)(4) receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation (rwmic) submitting report on behalf of richard wolf (b)(4).

• Brand Name: MONOPOLAR CUTTING ELECTRODE, 21FR
• Common Device Name: ELECTRODE
• Manufacturer (Section D): RICHARD WOLF GMBH (GERMANY); registration number 9611102; 32 pforzheimer street; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 6321651
• Report Number: 9611102-2017-00003
• Device Sequence Number: 551856
• Product Code: JOS
• UDI-Device Identifier: 04055207042885
• UDI-Public: 04055207042885
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2017

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
• Operator of Device: Physician
• Device Model Number: 8353.131
• Device Catalogue Number: 8353.131
• Device Lot Number: 1277723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: 01/10/2017
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE, OPTIK 30DEG, 2.7MM DIA 8974.402; ENDOSCOPE, OPTIK 30DEG, 2.7MM DIA 8974.402
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Weight: 92