MAUDE Adverse Event Report: RICHARD WOLF GMBH PRINCESS; CUTTING ELECTRODE BIPO

Model Number 46531323

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.

Event Description

As reported by the sales rep to customer service: hospital received a recent shipment of product number 46531323 (cutting electrode).The product in the packages are bivap electrode item# 46530243 (bivap electrode).The labeling was correct, the item was not.Additional details reported at the time:: 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? unknown.Was there any injury or illness to any other personnel due to the reported issue? unknown.Did the issue cause a delay in the procedure being performed? unknown.Did the delay put the patient at risk? unknown.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.Further investigation revealed: at what point was this problem found? for example were they prepping devices for surgery, stocking shelves, etc when they were doing the procedure, a hysteroscopic resection.Was there a patient involved? was a patient being prepped for surgery or on the table when this was discovered? the issue was found when they were opening the electrode during the procedure if yes to #2, did the problem cause a delay in the start of the procedure? slight delay, opened another electrode.

Manufacturer Narrative

Follow-up report #2 is to provide fda with product investigation results, missing information, new information, and changed information.Missing information: user facility was contacted twice directly in an effort to collect patient information and other missing details.Attempts were also made through the sales rep.Response from user facility, 9/17/2021, no additional infomration will be provided.Because the actual device was not returned for evaluation, the manufacturer reviewed the history of this part number and here is their statement: investigation report - product history evaluation: the query of the database has shown that since 2014 there has been a complaint ((b)(4)) of the 46531323 cutting electrode bipo 24.5ch.The cutting electrode bipo 24.5ch comes from the batch 4500138263 and was proceeded on (b)(6) 2014.The investigation has shown that the cutting electrode is bent at the guide and has visible impurities.The causes are due to mechanical overload and a cleaning error.Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rw mic considers this mdr closed.Follow-up reports will be sent to fda when/if additional information is received.

Event Description

The purpose of this report is to share the results of the product history report from rw gmbh.See manufacturers narrative.

Event Description

The purpose of this report is to share additional information about this mdr.Richard wolf initiated a product recall for lot 21002858 of 4653.1323 cutting electrodes bipo 24.5 fr on (b)(6) 2021.Reason for the recall: 4653.1323 cutting electrode bipo 24.5fr package may contain a 46530243 bivap electrode bipo 24.5fr.The recall is still open; waiting for affected customers to respond and then fda approval to close the recall.Hazard and risk: based on the package label, a user facility will identify, select, and deliver a 4653.1323 cutting electrode to the operating site.Upon opening and/or assembling the sterile electrode, the user may determine the electrode tip is incorrect.As a result, the scheduled procedure can be delayed or not carried out at all.This potential delay could be a risk to patient health.An "urgent safety information letter and response form" was sent to affected customers with instructions for scrapping (in-house) or returning affected devices to richard wolf and instructions for replacing their inventory.All devices in rw inventory were quarantined and will be scrapped once fda approves.

Manufacturer Narrative

Rw gmbh and rw mic are working together on the device recall.Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint open.Rw will submit a follow up report when new information becomes available.

• Brand Name: PRINCESS
• Type of Device: CUTTING ELECTRODE BIPO
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 12035643
• MDR Text Key: 267298930
• Report Number: 1418479-2021-00026
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207048979
• UDI-Public: 04055207048979
• Combination Product (y/n): N
• PMA/PMN Number: K060720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 46531323
• Device Catalogue Number: 4653.1323
• Device Lot Number: 21002858
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 07/28/2021; 09/15/2021
• Supplement Dates FDA Received: 08/27/2021; 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1