MAUDE Adverse Event Report: RICHARD WOLF GERMANY (RWGMBH) BIPOLAR RADIOFREQUENCY INSTRUMENT; PROBE, PRODUCT CODE GEI

Model Number	49936911
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Richard wolf medical instrument corporation (rwmic) was informed by facility that during a procedure the insulation near to the tip of the bipolar device melted away and separated.No injury to patient or staff reported.Manufacturing date: 28july2017, expiration date: 27july2020.Device was returned to rwmic and will be sent to supplier for investigation.User facility was contacted via email, in an effort to gather additional/missing medwatch information, no response as of 15feb2018.Rwmic considers this matter closed.However, in the event rwmic receives additional information, follow-up report will be submitted to fda.
Additional Manufacturer Narrative
(b)(4).Richard wolf medical instruments corporation (rwmic) received an investigation report from manufacturer rw (b)(4), report is dated (b)(6) 2018.Rw (b)(4) has determined that the user did not follow the instruction for use.Rf instrument shows massive wear of the insulation, thermal damage, and bent shaft.Damage is not manufacturing related, no product fault detected.Rwmic considers this matter closed, in the event rwmic receives additional information, a follow-up report will be submitted to fda.No files attached.
Event or Problem Description
Follow up report #1.
Additional Manufacturer Narrative
Follow up #1, the following was updated/completed: patient information, product problem, suspect device, importer (device), corrected/additional data.Richard wolf medical instruments corporation (rwmic) received an email from user facility, on 30jan2018, containing patient information.Follow up report to add information.Rmic considers this matter closed.However, in the event rwmic receives any additional information a follow report will be submitted to fda.

• Brand Name: BIPOLAR RADIOFREQUENCY INSTRUMENT
• Common Device Name: PROBE, PRODUCT CODE GEI
• Manufacturer (Section D): RICHARD WOLF GERMANY (RWGMBH); 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 7274918
• Report Number: 1418479-2018-00001
• Device Sequence Number: 16446620
• Product Code: GEI
• UDI-Device Identifier: 04055207054192
• UDI-Public: (01)04055207054192(11)170728(17)200727(10)73155
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2018
• Report Date (Section F): 04/26/2018

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: No Information
• Device Expiration Date: 07/27/2020
• Device Model Number: 49936911
• Device Lot Number: 73155
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/18/2018
• Device Age: 7 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 02/16/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 02/26/2018; 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 52
• Date Report Sent to FDA: 04/26/2018