MAUDE Adverse Event Report: RICHARD WOLF GMBH PIRANHA; FOOTSWITCH 1 PEDAL

Model Number	2030108
Medical Device Problem Codes	Mechanical Problem (1384); Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is filed under richard wolf gmbh complaint id: (b)(4).
Event or Problem Description
According to the information received, a holmium laser enucleation of the prostate (holep) and transurethral resection of the prostate (turp) procedure was scheduled.It was reported that during morcellation, the suction failed on one of the handpieces.The handpiece was replaced, and the suction is working.However, with the second handpiece, the morcellator blade no longer turned.The blade was replaced 4 times, without success.All attempts to troubleshoot, even with guidance from a service technician, were unsuccessful.Due to it, the scheduled operation was aborted.The patient must be readmitted when the device is ready for use again.
Additional Manufacturer Narrative
The following fields have new information: b4, g3, g6, h2, h3, h6 (type of investigation, investigation findings, and investigation conclusions), and h11.The device system involved in the incident which consisted of a suction pump (b)(6), motor control unit (b)(6)), foot switch 1 pedal (b)(6), 2 connection cables ((b)(6), and 2 motorized handpieces (b)(6) were tested in the specialist department at rwgmbh.The reported device foot switch 1 pedal, 2030108/(b)(6) was found with no errors.The overall investigation findings for the entire system, including one of the motorized handpieces (b)(6) with sn (b)(6), showed no defects and functioned perfectly.However, the other motorized handpiece (b)(6) with sn (b)(6), was found that the magnet in the magnet cover was corroded.This means that the valve provided for this purpose could not be properly locked in place, thus impairing the suction function.In addition, a crack was discovered in the weld seam on the suction pipe.Both defects may have caused the suction function to fail.The instructions for use, ifu ga-a202 / en / v13.0 / 2023-08 / pk23-0005, contains several safety checks and information regarding "loose or damage parts" in section 5 checks and section 5.1 visual inspections.Also, instructions to check devices for "completeness and corrosion" were stated.Furthermore, it was found that a valve was used with both handles; according to the instructions for use "ga-a202 / en / v13.0 / 2023-08 / pk23-0005", a "sealing insert - open" is provided for urological use, so that the suction function is permanently ensured.Section 6.2.8 power stick m4 with open sealing insert, explains the positioning of the rotary blade and the open sealing insert.In summary, we can say that the errors described by the customer (suction function and rotation of the blades) could only be partially reproduced.The problem with the suction function can occur with the motorized handle with the sn (b)(6) in the event of unfavorable handling and the defects found.However, the function of the blades could be ensured with both motorized handles.We therefore consider this case to be a "sporadic failure", and the cause of the fault cannot be traced.Possible risks such as functional failure of the product/product components were considered in the risk assessment e3-1, v00: "suction pumps with accessories", under "chemical hazards: anesthetic agents, administration of (additional/other) anesthetic agents to patient", and assessed as acceptable with the corresponding severity and probability of occurrence.

• Brand Name: PIRANHA
• Common Device Name: FOOTSWITCH 1 PEDAL
• 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: 20566608
• Report Number: 9611102-2024-00036
• Device Sequence Number: 7872504
• Product Code: JCX
• UDI-Device Identifier: 04055207054734
• UDI-Public: 04055207054734
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: Health Professional
• Device Model Number: 2030108
• Device Catalogue Number: 2030108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONNECTION CABLE WL 3M, BATCH# 100157, (B)(6).; PIRANHA SUCTION PUMP 2208, SN (B)(6).; POWER CONTROL 2303, SN (B)(6).; POWER STICK M4 (8564.121) SN (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male