MAUDE Adverse Event Report: RICHARD WOLF GMBH CUTTING ELECTRODE BIPOLAR 24-26 FR 12/30 DEGREE

Model Number	46222513
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Actual device is not returned yet.Investigation is currently in process.(b)(4) considers this report open, follow-up report to be submitted once investigation is complete.(b)(4).
Event or Problem Description
During the use, the wire loop electrode detached and remained in the uterus of the patient.Second electrode was used and detached and remained in uterus.Two mdrs to be submitted: 9611102-2018-00002, 9611102-2018-00003.
Additional Manufacturer Narrative
(b)(4).An investigation was unable to be performed as the device was not returned to the manufacturer.Multiple attempts were made to contact the user facility, but no response was provided.Richard wolf gmbh (rwgmbh) considers this matter closed.In the event rwgmbh receives additional information a follow up report will be submitted to fda.
Event or Problem Description
Follow up report to provide additional information to fda.

• Brand Name: CUTTING ELECTRODE BIPOLAR 24-26 FR 12/30 DEGREE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 7311124
• Report Number: 9611102-2018-00002
• Device Sequence Number: 13490479
• Product Code: JOS
• UDI-Device Identifier: 04055207048887
• UDI-Public: 04055207048887
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 46222513
• Device Catalogue Number: 46222513
• Device Lot Number: 4500224068
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2018
• Supplement Date Received by Manufacturer: 02/17/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 01/17/2019
• 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: BIPOLAR CABLE; FOOT SWITCH; GENERATOR; SCOPE; WORKING ELEMENT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR