MAUDE Adverse Event Report: RICHARD WOLF GMBH MOTOR HAND PIECE

Model Number 8564.021

Device Problems Contamination /Decontamination Problem (2895); Failure to Clean Adequately (4048)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

Rwmic will follow up with the user facility and manufacturer to obtain additional and missing information.Rwmic considers this case open.

Event Description

On (b)(6) of 2018, the user facility reported the following to richard wolf medical instruments (rwmic): for about 1-1.5 years the facility has had a difficult time thoroughly cleaning the motor hand pieces (part number 8565.021); tissue is found within the device even after extensive cleaning.On (b)(4) 2018 the sales representative reported that had visited the facility on (b)(4) of 2018, to walk through the device cleaning process.After cleaning the device themselves, the sales representative observed that there was tissue left inside the hand piece.Motor hand piece (part number 8564.021/serial number (b)(4)) - mdr 1418479-2018-00044.Motor hand piece (part number 8564.021/serial number (b)(4)) - mdr 1418479-2018-00045.Motor hand piece (part number 8564.021/serial number unknown) - event date (b)(6) 2018 - mdr 1418479-2018- 00046.Motor hand piece (part number 8564.021/serial number unknown) - event date (b)(6) 2018 - mdr 1418479-2018- 00047.All other unknown occurrences will be captured in mdr 1418479-2018-00048.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? no.Specifically, was the device being used on a patient when the issue occurred? no.Was there any injury or illness to patient or other personnel due to issue? n/a.Did the issue cause a delay in the procedure being performed that put the patient at risk? n/a.Was there a similar back-up device available for use? n/a.Was the scheduled procedure completed? n/a.How was the patient anesthetized? not applicable.

Manufacturer Narrative

Follow-up report #1 is to provide fda with new information: results of the device investigation (see below).Adverse event codes (h6) were updated.Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.This mdr is being submitted as part of an ongoing retrospective review (remediation) of prior files by rwmic.The device was received and evaluated by rw mic.According to the investigation report: product appearance: used.Complaint condition verified: no, no tissue found.Repeat repair: no, no repair history.Med specifications: yes.Test method: visual, functional, electrical and mechanical means equipment used: 2208011, 2303011, vacuum canister set and meter probable root cause: no tissue or obstruction was found, o-ring missing conclusion: o-ring will be replaced.Locking lever will be replaced as preventative maintenance.Complaint valid: no, no tissue found action required: repair, replaced o-ring and locking lever.Function tested, meets specification.Device labeling (ga-a238) was reviewed for patient code and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed, ifu contains directions for reprocessing and maintenance of the device: 7.2.1 maintenance intervals: important! to avoid any incidents or damage caused by aging and wear it is necessary to service the product and the accessories at adequate intervals.Depending on the frequency of use, but at least once a year, have an expert check the functional and operational safety of the equipment.7.3 reprocessing procedure: important! disinfectants containing peracetic acid without corrosion protection, phenoles or chlorine components must not be used for the reprocessing of richard wolf products.Strictly adhere to the maximum immersion time in the disinfectants used, as described by the manufacturers.Important! 'when used as intended following the instruction manual, it is not necessary to limit the number of permissible reprocessing cycles.'careful and gentle handling of medical products during the entire reprocessing process has an essential influence on the service life of the products.'before returning defective products for repair, they must have been subjected to the entire reprocessing cycle.'the user must make sure that the reprocessing process including the resources, materials and personnel is suitable for yielding the required results.Important! do not sterilize the products in hot-air sterilizers.Important! do not clean plastic parts with metal or sharp-edged tools (such as sharp edged brushes).Note! machine cleaning is to be preferred.Manual cleaning / disinfection can be carried out if there is no possibility of machine cleaning/disinfection.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

Event Description

The purpose of this submission is to report the results of the device investigation.See manufacturers narrative.

• Brand Name: MOTOR HAND PIECE
• Type of Device: MOTOR HAND PIECE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8122508
• MDR Text Key: 129755375
• Report Number: 1418479-2018-00046
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/30/2018,05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 8564.021
• Device Catalogue Number: 8564.021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2018
• Distributor Facility Aware Date: 11/02/2018
• Event Location: Other
• Date Report to Manufacturer: 11/30/2018
• Date Manufacturer Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1