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

Model Number 8564021

Device Problem Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  Injury  

Manufacturer Narrative

The motor handpiece max.6000rpm, 8564.021 with the serial number (b)(6) was inspected in the specialist department.As the customer only sent in the motor handpiece, the function was tested with the suction hose and suction pump from the specialist department.With this constellation, the fault described by the customer could not be detected; the motor function and seal were intact.The o-rings on the blade holder and valve were routinely replaced as part of the inspection.The instrument, 8564.021, sn# (b)(6) was manufactured on 27/nov/2015.It was delivered to the customer on 11/feb/2016.On 16/may/2023 the handle was sent in for repair, repaired and returned on july 05, 2023.A connection to the present complaint is not recognizable.An evaluation of the complaints has shown that another serial number was claimed on 20/feb/2017.It was found that during/after reprocessing, the o-ring on the blade attachment was forgotten.The error is to be considered as user error.The instructions for use ga-a238 / en / 2020-10 v10.0 / pk20-0257 / section 4.4 preparation - describes how to properly install and connect the power stick m4 together with the suction tube, connection cable to power drive art1.In addition, section 9.1 - troubleshooting, clearly lists the possible error causes and their corresponding corrective measures for no or insufficient suction.Possible hazards were considered in the risk assessment e5-2 "motorized handles" v00 with the relevant extent of damage and probability of occurrence under "chemical hazard: administration of additional anaesthetic" as "application error: incorrect assembly by user" and assessed as acceptable with the following mitigation: - risk-20582: in ifu: description of assembly.- risk-20596: caution in ifu: incorrect or inadequate assembly of products.Carry out a functional check before each use.The identified defect does not describe a general product problem that corresponds to a non-conformity, negative trend or previously unknown hazards.Since the incident relates to a handling error, a systemic problem is not detectable and the warnings in the instructions for use ga-a238 / en / 2020-10 v10.0 / pk20-0257 / are considered adequate, no further action will be taken with regard to this incident, apart from monitoring further cases to determine a possible trend.In summary, it can be said that the customer only sent in the motor hand piece without the rest of the control unit and rwgmbh was unable to detect the fault described by the customer.We assume that the fault could also have been caused by other factors, which is why we assume improper use.The instructions for use describe the correct preparation as well as the possible causes of the fault and the corrective measure.

Event Description

A medical supplier 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, during the operation (morcellation of the prostate), the motorized handle failed so that no vacuum could be generated.The scheduled procedure was completed.However, the operation time was extended by an hour.There is no report of injury to the patient or other personnel.

• Brand Name: POWER STICK M4
• Type of Device: 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: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 18573542
• MDR Text Key: 333626261
• Report Number: 9611102-2024-00002
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 04055207017982
• UDI-Public: 04055207017982
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8564021
• Device Catalogue Number: 8564.021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other