MAUDE Adverse Event Report: RICHARD WOLF GMBH POWER STICK M4; MOTOR HANDPIECE MAX. 6000RPM

Model Number	8564021
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The motor handle has not yet been sent in by the user for examination.
Event or Problem Description
A medical distributor has informed richard wolf gmbh of an issue regarding a motor handpiece max.6000rpm, part id: 8564.021, sn # (b)(6).According to the received information, after the laser enucleation of the prostate was completed, the health professional tried to use the power stick for morcellation and suction.The motorized handpiece worked briefly for 5-10 seconds, then suction failed.The handpiece was checked and reloaded probe/blade.Also, connections of the sterile disposable tubing, filter, and canister were checked several times.However, the suction could not be generated, and therefore surgery was abandoned.The patient returned the following day with an acute condition.A second handpiece was used with the same motor control unit 2304 and the suction and morcellation was completed.Later information received confirmed that the patient has no negative medical events after the first procedure.

• Brand Name: POWER STICK M4
• Common Device Name: MOTOR HANDPIECE MAX. 6000RPM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 20347489
• Report Number: 9611102-2024-00032
• Device Sequence Number: 7880180
• Product Code: GEY
• UDI-Device Identifier: 04055207017982
• UDI-Public: 04055207017982
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2024

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: 8564021
• Device Catalogue Number: 8564.021
• Device Lot Number: 1101004715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2023
• 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: PART ID: 2304.007 - MOTOR CONTROL UNIT 2304
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown