MAUDE Adverse Event Report: RICHARD WOLF GMBH PRINCESS; HOOK ELECTRODE 21/24.5FR

Model Number	4653033
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Richard wolf has requested the device to be returned.
Event or Problem Description
The user facility representative reported that during a case, the tip of the hook electrode 21/24.5fr, part # 4653033 broke off.The tip broke while surgeon was resecting tissue around embedded iud (intrauterine device) in the cervix.According to surgeon, she pulled out the broken piece and it fell on the floor.Staff was not able to locate the piece.An x-ray was performed.Additional information was received from the user facility representative on january 20, 2023.According to the received information, there was a delay of 30 minutes to find and retrieved the broken piece out of the patient's cervix.The user facility performed an x-ray to be sure no foreign body remained in the patient.The user facility confirmed that the x-ray was negative.The intended surgery procedure was completed and the outcome was favorable.

• Brand Name: PRINCESS
• Common Device Name: HOOK ELECTRODE 21/24.5FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 16366929
• Report Number: 1418479-2023-00003
• Device Sequence Number: 7390680
• Product Code: FAS
• UDI-Device Identifier: 04055207053362
• UDI-Public: 04055207053362
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/13/2023
• Report Date (Section F): 02/13/2023

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: Other
• Device Model Number: 4653033
• Device Catalogue Number: 4653033
• Device Lot Number: 21003678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/19/2023
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/13/2023