MAUDE Adverse Event Report: RICHARD WOLF GMBH FOOTSWITCH 2 PEDALS

Model Number 2304.901

Device Problems Display or Visual Feedback Problem (1184); Device Displays Incorrect Message (2591); Appropriate Term/Code Not Available (3191)

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

Event Date 02/02/2022

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report on behalf of the manufacturer richard wolf (b)(4).Richard wolf medical instruments corporation is the importer of this device.Rw gmbh considers this mdr open.A follow up report after the device evaluation has been completed and/or new information becomes available.

Event Description

It was reported to richard wolf: "(b)(6) the local rep, during the procedure.When the footswitch for the powerdrive art1 was activated, the controller displayed a "footpedal defective" error message.The rep asked them to disconnect and re-connect the footswitch, and the message was no longer displayed.When they started the procedure, the handpiece wasn't rotating the burr.They disconnected the cable from the handpiece and generator, and re-connected.The handpiece still would not rotate the burr.Then the rep called me to conference with the operating room, and that's when the physician stopped the case.He had made an incision, stopped the case, closed the incision, and will re-schedule.(b)(6) the local sales rep went to the account and determined that the (2) 89955.0000 m4 motor handpieces and the 8564.851 connecting cable were functioning properly, and will not be returned to us for evaluation." will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? yes.Was there a similar back-up device available for use? no.Was the scheduled procedure completed? yes.

Manufacturer Narrative

Follow-up report #1 is to provide fda with missing information, new information, and changed information.New information: the following fields have new information: section a (patient metrics), b5 additional information about procedure.Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rw gmbh considers this mdr open.Rw gmbh will submit a follow up report after the device evaluation has been completed and/or new information becomes available.

Event Description

We received new information from the device importer about the patient and the procedure.See section a for patient information.Other information received: 1.Outcome attributed to adverse event: procedure stopped, incomplete.2.Purpose for procedure: treatment.3.What was the procedure: knee arthroscopy.4.Device serviced/repaired by a third party: no.5.Operator of device: surgeon and surgical tech.

Event Description

Rwmic reference complaint no.(b)(4).The purpose of this submission is to report the results of the device investigation and corrected informations.Rwmic mdr awareness date: 02-feb-2022.

Manufacturer Narrative

Follow-up report #2 is to provide fda with the results of the device investigation.The following fields have new information: d4 (lot #), d9 (returned to manufacturer), h6 (investigation codes).Corrected fields: a4, d2 (common device name & product code), d4 (model# and udi#).According to rwgmbh investigation report device evaluation, form 5020 (12): (07/11/2022) device was returned but by-passed the complaint process.Complaint investigation is based on the assessment of the available information from the evaluation and repair performed under service order (b)(4).According to the repair report, the sealing cap/rubber cap on the cover rocker switch is jammed, the device base was missing.The root cause is a material failure of the sealing cap/rubber cap produced and delivered between 2013 and 2014 from a supplier.This material failure occurs over time.The associated change request 9d-report from 12-07-2017 requires that during any maintenance or repair the defective material should be changed.However, there is no record about a maintenance or repair of the reported device since the delivery of 02/27/2015 either at rwmic's nor at rwgmbh's side.The user is advised in the related ifu ga-a 238-usa/usa/2012-10 v5.0/eco 2012-0554 & ga-a238-us/en/2020-12 v6.0/pk20-0352 about the regular maintenance of the device in section 7.2.1 maintenance intervals.Therefore, the delay and the cancellation of the procedure were caused by the failed maintenance of the device since delivery.Richard wolf medical instruments corporation (rwmic) considers this mdr closed.Rwmic will submit an additional report if new information becomes available.Richard wolf gmbh (rwgmbh) considers this mdr closed.Rwgmbh will submit an additional report if new information becomes available.

• Brand Name: FOOTSWITCH 2 PEDALS
• Type of Device: FOOTSWITCH 2 PEDALS
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 13559177
• MDR Text Key: 296407725
• Report Number: 9611102-2022-00007
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2304.901
• Device Catalogue Number: 2304.007
• Device Lot Number: 150587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2015
• 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
• Treatment: BURR.; CONNECTING CABLE.8564.851.; FOOTSWITCH 2 PEDALS.2304.901.; POWERSTICK M5/0.89955.0000.
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native