MAUDE Adverse Event Report: RICHARD WOLF GMBH MOTOR CONTROL UNIT 2303

Model Number 2303001

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

Instrument has not yet been sent in by the user for examination, so no statement can be made at this time.A follow up report will be submitted with the investigation results.

Event Description

The following was reported to rw gmbh: after laser resection of the prostate, the adenoma could not be morcellated, the foot switch enabled suction, when the morcellation button was pressed, no reaction resulted.After checking all cables,restarting the system,no function could be obtained.Second operation required to morcellate the prostate adenoma after receiving the replacement device.

Event Description

The follow up report #1 is to provide additional information and device evaluation.

Manufacturer Narrative

The description in the questionnaire shows that the following devices were directly involved in the operation: wolf piranha 2208, wolf foot switch, wolf morcellator.We assume that the devices involved with regard to their installation led to increased emission of electromagnetic radiation or reduced interference immunity, and thus caused the failure of the motor control unit 2303001 with sn (b)(6).The cause is due to a user error.The motor control unit 2303001 with sn (b)(6) was booked into stock on 01.06.2016.The production order (b)(4) consists of 4 motor control unit 2303001.The motor control unit 2303.001 with the sn (b)(6) was delivered to the customer on 15.06.2016 (order number (b)(4)).No defect was detected during the last repair on 5.11.2018.In the ga-a202 /en/ 2018-11 v11.0 / pk18-9162 visual and functional checks before use are described.In the ga-a 202, the risk of malfunctions or malfunctions is clearly pointed out.For the safety of the user, patient and third parties, use only accessories and spare parts as specified by the manufacturer.Other accessories and spare parts may result in increased emission of electromagnetic radiation or reduced immunity to interference.Medical electrical equipment is subject to special precautions regarding electromagnetic compatibility (emc).Emc instructions regarding installation and operation must be observed.Medical electrical equipment may be affected by mobile portable rf communications equipment.If rf interference occurs when equipment must be stacked or is placed immediately adjacent to each other, the intended operation of the equipment should be observed.Possible hazards were considered in the risk assessment e5-1 r05 (control devices with accessories - power control with foot switch) with the corresponding extent of damage and probability of occurrence and were assessed with an acceptable risk.This assessment is still valid even taking into account the current case.Richard wolf gmbh (rwgmbh) considers this matter closed.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation (rwmic) is submitting this report on behalf of rwgmbh.

• Brand Name: MOTOR CONTROL UNIT 2303
• Type of Device: MOTOR CONTROL UNIT 2303
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11275645
• MDR Text Key: 231317227
• Report Number: 9611102-2021-00005
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• PMA/PMN Number: 888.1100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2303001
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1