MAUDE Adverse Event Report: RICHARD WOLF GMBH N/A; HF CONNECTION CABLE MONO L 3M REUSABLE

Model Number 815033

Device Problems Break (1069); Temperature Problem (3022)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Labeling review ( ga-s009).Important general notes and instructions: make sure that this product is used only as intended and described in this instruction manual and by adequately trained and qualified medical personnel, maintenance and repair must be carried out by authorized experts.Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual.Use other combinations, accessories and replacement parts only if they are expressly intended for the planned application and if the performance characteristics and safety requirements are met.The product must not be altered in any way.Reprocess the product in accordance with the manual before every use and before return shipment to protect the patient, user and third parties.This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle.This manual must be passed on to any subsequent owner or user.Immediately upon receipt, check the product and its accessories for completeness and possible damage.Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately.Warning! hf cables with defective, brittle or cracked insulation can cause burns to the user or patient.If the electrical line breaks, an arc can occur causing burns to the user or patient or start a fire, regardless of whether the insulation is also damaged or not.Never use or repair defective hf cables! always replace them.Do not modify hf cables! the monopolar cables may be operated at a maximum recurrent peak voltage of 4000 vp and the bipolar cables at max.1000 vp.Caution! do not clean hf cables in an ultrasonic cleaner.Rwmic considers this mor/complaint open.Rwmic will contact the user facility for missing patient information.

Event Description

On october 5th, 2020, the user facility reported the following to richard wolf medical instruments corporation (rwmic): the loops were completely burning out and breaking during a turp.We went through 5 different loops in one case and it ended.Up charring the end of the sheath which led to bits of metal breaking off into the patients body.Will the device be returned? yes.Was the device being used during a procedure when the 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? (only applicable if there was a report of delay) unknown.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.Rwmic device evaluation 10/22/2020 : visual, functional and electrical test method determined that the cable is worn from age and use.The connector was oxidated and a replacement is suggested by our repair department.Normal wear and tear was determined to be the root cause.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.On february 4th, 2021, rwmic received new information from the initial reporter.According to the user facility, rwmic products were used with a medtronic generator which was causing the issue.Labeling review (ifu: ga-d366): caution! do not combine products incorrectly! injuries of the patient, user or others as well as damage to the product are possible.The different products may only be used together if their intended uses and the relevant technical data (working length, diameter, peak voltage, etc.) are the same.Follow the instruction manuals of the products used in combination with this product.Follow the "notes and instructions on hf applications", order no.: ga-s 002 as well as the hf device manufacturer's instructions.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.Warning! danger of electric shock! patient leakage currents can add up if the endoscopes are combined with other powered endoscopic accessories.Make sure that the combinations do not exceed the permissible patient leakage currents.Caution! careful if hf voltage is too high! danger of injury resulting from damage to the electrode insulation! exceeding the maximum recurring peak voltage for the electrode in combination with hf surgical devices and / or selecting the wrong mode can destroy the insulation and cause leakage currents.The patient, user or others may suffer tissue damage! use electrodes in conjunction with hf surgical devices only at a recurring peak voltage of max.2 kv, even in forced or spray coagulation.We recommend using the following power settings: single-use electrodes cutting mode: 120 - 180 watt.Coagulation mode: maximum 100 watts.Caution! careful if hf output power is incorrectly selected! injuries of the patient as well as damage to the product are possible.The power should be set on the basis of the surgeon's experience and training in view of the corresponding indication.Rwmic considers this mdr and complaint closed at this time.If additional information become available, a follow up report will be submitted.

Event Description

On february 4th, 2021, rwmic received the following information from the sales rep: in discussions with the user facility and the doctor it was determined that it was a medtronic generator causing the issue.The customer was having to use 3-4 loops per turp.We exchanged out the generator in the cysto room and found it was the medtronic generator that was causing the loops to burn out.The customer has send the medtronic generator for repair and is using one out of another room.

• Brand Name: N/A
• Type of Device: HF CONNECTION CABLE MONO L 3M REUSABLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10756256
• MDR Text Key: 243687300
• Report Number: 1418479-2020-00038
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04055207000236
• UDI-Public: 04055207000236
• Combination Product (y/n): Y
• PMA/PMN Number: K982677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

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: Health Professional
• Device Model Number: 815033
• Device Catalogue Number: 815033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 10/06/2020
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1