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

Model Number 4653033

Device Problem Material Disintegration (1177)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

Richard wolf has requested the device to be returned.

Event 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
• Type of Device: HOOK ELECTRODE 21/24.5FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 16366929
• MDR Text Key: 309492882
• Report Number: 1418479-2023-00003
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207053362
• UDI-Public: 04055207053362
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 02/13/2023
• Distributor Facility Aware Date: 01/19/2023
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/13/2023
• Patient Sequence Number: 1