MAUDE Adverse Event Report: RICHARD WOLF GMBH; FOOTSWITCH 2 PEDALS L 5M

Model Number	2260021
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information received, when using the foot switch, a sales representative from richard wolf france noticed that the colours of the pedals had been mixed up.The operation was carried out, taking care to use the correct pedal for the correct function.It has been reported that no patient injuries occurred.
Additional Manufacturer Narrative
During quality control, it was discovered that the color coding of the pedal caps was reversed in a production batch of foot switches type 2260021.The foot switch with serial number (b)(6) from grenoble is affected.The color coding and arrangement of the pedals are described in several chapters of the ga -a339 / en / us / v4.0 /2024-09 / ek24-0180 operating instructions.According to the instructions for use (ga-a339) and the requirements of the iec 60601-2-2 standard, the left pedal cap should be yellow (cutting) and the right pedal cap blue (coagulation).However, the color coding on the affected products is reversed: blue on the left (cutting) and yellow on the right (coagulation).The electrical functionality is correct; only the color caps do not comply with the requirements of the standard.This deviation from the established color coding poses a relevant product risk.In a typical surgical situation, surgical staff often rely on the color coding of the foot switches, especially in hectic or emergency situations where quick decisions have to be made.Under these circumstances, confusion between the pedal functions cannot be ruled out, especially since the user's attention is mainly focused on the surgical field and the acoustic signals of the device.Even if the signal tones are correct and the electrical functionality is intact, the incorrect visual guidance provided by the color caps must be considered critical.Although the instructions for use require a visual inspection and functional test of the pedals before each use, this reduces the risk but cannot completely eliminate it, especially under real life conditions in everyday clinical practice.Accidental activation of the cutting function instead of coagulation can result in injury to the patient, such as unwanted cuts, bleeding, or prolonged procedures.Delays in the surgical procedure due to uncertainty or queries are also possible.Furthermore, it should be noted that color coding is not only an internal requirement but also part of the applicable standards.This means that there is not only a potential risk of misuse but also a deviation from the regulations.The color reference is correctly described in the instructions for use (left = yellow, right = blue), but this contradicts the actual design and may cause additional confusion.Based on the results of the investigation, richard wolf gmbh (rw gmbh) has decided to replace the defective foot switches from the affected batch as part of an fsca outside the usa.No foot switches from the affected batch were delivered to the usa.

• Common Device Name: FOOTSWITCH 2 PEDALS L 5M
• 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: oliver ehrlich ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 22090915
• Report Number: 9611102-2025-00024
• Device Sequence Number: 20838755
• Product Code: GEI
• UDI-Device Identifier: 04055207063330
• UDI-Public: 04055207063330
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K230194
• 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,Followup
• Report Date (Section B): 07/08/2025

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: 2260021
• Device Catalogue Number: 2260021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown