MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE; HOOK ELECTRODE MONO 9FR 0°

Model Number	868895
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during the surgical procedure, the metal hook broke off in the patient's body.The missing fragment went out with the instrument and no medical follow-up needed.Also, it was reported that the procedure was completed without additional unscheduled medical measures.There was no report of any patient harm.
Additional Manufacturer Narrative
The hook electrode mono 9fr 0°, part number: 8688.95, batch number 1548338, was examined at richard wolf gmbh (rw gmbh).The examination revealed the following: investigation/analysis: the monopolar hook electrode that was sent in is missing a distal hook.The break occurred directly at the solder joint between the hook and the tube, with part of the solder joint still intact.The microscopic image shows slight thermal effects on the insulating tube.The break edge itself has a crater-like, rough structure.Assessment: no information is available on the number of previous reprocessing cycles and applications of the reusable electrode.The hf generator settings specified by the user do not comply with the instructions for use.According to the ifu, the generator setting "spray coag" is not permitted, as very high peak voltages are reached even at low settings.According to the instructions for use of the erbe vio 300d hf generator used, the "spray coag" current type already uses a peak voltage of >1kv at the lowest effect setting.The use of a generator setting that does not comply with the specifications will result in the insulation strength of the electrode being exceeded and, if necessary, an electrical flash-over within the electrode.In addition, the high voltages at the distal application part (in particular due to the delicate design of the distal application part of this electrode, which is necessary for the application) can cause sparking and very high temperatures.This can lead to breakage or melting of the distal application part due to thermal stress.The damage to the electrode indicates excessive heat exposure of the hf current on the distal application part, and therefore the generator setting used may be a possible explanation for the damage pattern.The ifu ga-d302 / en / 2015-03 v5.0 / pk18-9297 contains the following safety instructions: 7 additional notes and instructions for use 7.2 hf applications caution! careful if hf voltage is too high! danger of injury resulting from damage to the electrode insulation! exceeding the maximum recurring peak voltage for the electrode in combination with hf surgical devices and / or selecting the wrong mode can destroy the insulation and cause leakage currents.The patient, user or others may suffer tissue damage! use electrodes in combination with hf surgical devices only with a maximum recurring peak voltage of 1.0 kv.Do not carry out forced coagulation or spray coagulation.We recommend using the following power settings: -electrodes.Cutting mode: 100 watt.Coagulation mode: maximum 60 watt.Caution! thermal tissue damage due to damaged insulation! in the case of hf instruments that have been reprocessed often, or aged hf instruments the insulation may be damaged.Damaged insulation causes leakage currents that lead to tissue thermal injuries of the patient, user and others.Check the insulation for damage before use.Do not use hf instruments with damaged insulation.Caution! danger of hf arcing! insufficient distance between parts carrying high-frequency current and other conductive parts can cause unintended tissue damage and damage to the instrument.When the hf current is activated, parts of hf instruments carrying high-frequency current must have a minimum distance of 2.5 mm from the distal end of the endoscope.In the case of hf sparking, replace the electrode immediately, check the endoscope for damage and return for repair if necessary to avoid consequential damage.A definitive assessment of the cause cannot be made at present, as the damage pattern cannot be attributed to a single event or cannot be traced.The subject issue is present in the risk management file b2-3 reusable resection electrodes, v00.The overall probability of occurrence for this issue is consistent at previously defined levels and the overall risk of the device remains in the acceptable category.In summary, it can be said that the hook electrode mono 9fr 0°, does not have a general product problem.A recent evaluation of product monitoring shows no abnormalities regarding similar damage to this product.Richard wolf gmbh (rw gmbh) has submitted a comparable reportable serious incident in the last two years and therefore have considered to report this case to be a reportable malfunction.

• Brand Name: E-LINE
• Common Device Name: HOOK ELECTRODE MONO 9FR 0°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 22414252
• Report Number: 9611102-2025-00029
• Device Sequence Number: 18560196
• Product Code: FAS
• UDI-Device Identifier: 04055207011126
• UDI-Public: 04055207011126
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K980302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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?: No
• Operator of Device: Other
• Device Model Number: 868895
• Device Catalogue Number: 8688.95
• Device Lot Number: 1548338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ERBE, VIO 300D
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown