MAUDE Adverse Event Report: RICHARD WOLF GMBH PRINCESS; CUTTING ELECTRODE BIPO 21FR FOR HYSTEROSCOPY

Model Number 46531313

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

Rwmic considers this case open.The manufacturer and user facility will be contacted to collect missing information.A follow up report will be submitted upon receipt of new or additional information.

Event Description

On (b)(6) 2020, the user facility reported the following to richard wolf instruments corporation (rwmic): the loop disintegrated during a very long procedure, large fibroid.The device was being used on the patient when the issue occured, but there was no patient/staff injured reported.There was a delay in the procedure, but there was no patient risk associated with the delay.Will the device be returned? no.Was the device being used during a procedure when the issue occurred? yes.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? yes.Did the issue put the patient at risk? no.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.

Manufacturer Narrative

Richard wolf mic is submitting this follow-up report on behalf of richard wolf gmbh.Rwmic is importer of the device.The user facility was contacted three times in an effort to collect patient and user information.As of this date, richard wolf mic has not received a response.New or change information in the following sections: b4, b5, g6, h2, h6, h10.Labeling review (ga-d349): caution! the products have only limited strength! excessive force will cause damage, impair the function and therefore endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Make sure that no missing parts remain in the patient.Do not use the products if they are damaged or incomplete or have loose parts.Caution! if the power setting is too high above the value recommended by the manufac­turer there is the risk of increased thermal damage and abrasion as well as breakage of the electrode loop (wire).Caution! continuous activation of the bivap electrode causes thermal damage! high levels of heat or distal wear to the electrode insulation may be the result.Note! excessive power settings can cause clearly increased electrode wear.We recom­mend starting at a lower power setting to determine the optimum power setting.Caution! be careful if products are damaged or incomplete! injuries of the patient, user and others are possible.Run through the checks before and after each use.Do not use the products if they are damaged, incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.Richard wolf mic considerrs this mdr closed if additional information becomes available another follow-up report will be submitted.

Event Description

The follow-up #1 is to report new or additional informatin to fda.

Manufacturer Narrative

Follow-up report #2 is to provide fda with the investigation report - product history evaluation, missing information, new information, and changed information.New information: the following fields have new information: b5, g2-g3, h2, h10.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

The purpose of this submission is to report the results of the product history evaluation.The manufacturer reports: ""within the last three years (>09.01.2018) richard wolf gmbh received only one complaint with this product.During the same time more than (b)(4)packs (3 pieces/pack) have been sold worldwide.The received investigation complaint was from a french customer and was received in (b)(6) 2021 - the investigation showed that the distal wire was bent and the insulating tube was pushed forward together with the guide tube.Because of that an electrical shortcut was caused.Root cause was determined as a user error.According to our experience excessive power settings on the hf generator can lead to rapid wear and tear which leads to breakages of distal parts.To avoid such damages during hf application the user is advised in the instruction manual ga-d349 with several notes about the dangers of monopolar and bipolar use.If the power setting is too high above the value recommended by the manufacturer there is a risk of increased thermal damage and abrasion as well as breakage of the electrode loop (wire).Due to an incorrectly selected hf output power injuries to the patient and damages of the products are possible.".

• Brand Name: PRINCESS
• Type of Device: CUTTING ELECTRODE BIPO 21FR FOR HYSTEROSCOPY
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10276332
• MDR Text Key: 204775841
• Report Number: 1418479-2020-00014
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207048962
• UDI-Public: 04055207048962
• Combination Product (y/n): N
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2020,10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 46531313
• Device Catalogue Number: 4653.1313
• Device Lot Number: 4500266367
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2020
• Distributor Facility Aware Date: 03/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2020
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1