MAUDE Adverse Event Report: RICHARD WOLF GMBH PIEZOWAVE2; PIEZOWAVE 2 CONTROL UNIT

Model Number	100506
Medical Device Problem Codes	Image Display Error/Artifact (1304); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information received, a fault message and subsequent smoke development occurred during an application of the piezowave 2.The piezowave was disconnected from the power supply.The user reports that there was no danger to the patient.
Additional Manufacturer Narrative
The following fields have new information: b4, d8, g3, g6, h2, h3, h6 (type of investigation, investigation findings, and investigation conclusions), h7, h8, and h11.The investigations revealed that a high-voltage capacitor had a manufacturing defect.The coated base material (film) had a defective coating on a roll of film.The capacitors manufactured from this material can exhibit a similar defect.Depending on the voltage and current load, electrical breakdowns occur in the capacitor, which can lead to smoke development, which is conveyed to the outside by the ventilation fan.The materials used are self-extinguishing.We therefore assume that the user suspected a fire due to the smoke.Due to the manufacturing defect at the manufacturer capacitor and this incident, richard wolf has decided to inspect all devices on the market that contain capacitors from the affected film roll.The measure was reported to the federal institute for drugs and medical devices (bundesinstitut für arzneimittel und medizinprodukte, bfarm ) and is listed under the bfarm case number: (b)(4).Additionally, there are no devices in us that was affected by the recall action.

• Brand Name: PIEZOWAVE2
• Common Device Name: PIEZOWAVE 2 CONTROL UNIT
• 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: 20667015
• Report Number: 9611102-2024-00037
• Device Sequence Number: 12572515
• Product Code: ISA
• UDI-Device Identifier: 04055207063989
• UDI-Public: 04055207063989
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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: Health Professional
• Device Model Number: 100506
• Device Catalogue Number: 100506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown