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  

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.

Manufacturer Narrative

Richard wolf has requested the device to be returned.

Manufacturer Narrative

The visible changes on the hook electrode indicates mechanical and/or thermal-electrical overloads.However, the probable root cause of the findings cannot be exactly determined, because there is no information about the duration of the procedure, the used hf generator and its settings as well about the used device combination.Excessive force exerted by the user may result in mechanical failure of the hook electrode.When using hf current, ageing occurs on the hook.This wear depends on many factors such as the type of the hf generator, the settings of the hf generator, the tissue contact, the duration of use etc.Excessive power settings on the hf generator can already cause rapid wear within one usage, which can eventually lead to breakage of the hook.The hook electrode 21/24.5fr 4653033, batch # 21003678 was manufactured on 10/feb/2022.The batch consisted of 19 pak.One pak consists 3 hook electrodes.No issues were identified during production.No further complaints were received neither from the same batch nor from another batch.The ifu ga-d 349 / en-us / 2015-02 v6.0 / eco 2014-0506 contains safety instructions and notices about avoiding use of excessive force in section 7 use as well as about the chosen hf generator setting in section 7.2.5 hf - application (monopolar / bipolar).Furthermore, the user is informed about the increased wear of the hook electrode while using excessive power settings in section 7.2.5.2 hf application (bipolar).The subject issue of breakage of the device is present in the risk management file bb2-3: non-reusable resecting electrodes, rev.: 05.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: PRINCESS
• Type of Device: HOOK ELECTRODE 21/24.5FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 2; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• Manufacturer Contact: zsófia bartholome-nagy ; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• MDR Report Key: 16366925
• MDR Text Key: 309505735
• Report Number: 9611102-2023-00006
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207053362
• UDI-Public: 04055207053362
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2022
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian