MAUDE Adverse Event Report: RICHARD WOLF GMBH S-LINE; WORKING ELEMENT ACTIVE BIPO 0/12/30°

Model Number 8680204

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2022

Event Type  malfunction  

Event Description

It was reported to richard wolf by the customer that: "all slings burned out during bipolar resection during surgery.There was a surgical delay of 20-30 minutes.The patient had to be transferred to intensive care due to tur syndrome.".

Manufacturer Narrative

Rwmic is submitting this report on behalf of the legal manufacturer richard wolf gmbh.According to the production control plan, there was no abnormality from the affected lot.As soon as the instrument has been sent in by the user, the investigation will be started.Rwmicrwgmbh will submit a follow up report after the device evaluation has been completed and/or new information becomes available.

Manufacturer Narrative

Follow-up report #1 is to provide fda with new information: device investigation report from rw gmbh, manufacturer: according to the customer, multiple annealing of the slings and obturator irritation occurred during a prostate resection with bipolar electrodes.According to pictures provided by r.Wolf sales staff, an hf generator "erbe vio 300" with resection adapter was used.Information about generator settings is not available.There was a surgical delay of 20-30 minutes.The patient had to be transferred to intensive care due to a tur syndrome.The following richard wolf instruments were used: 2x 8680.204 working element active bipo 0/12/30° batch number 1495009.2x bipol.Coagulation electrode item no.8622131 batch number 1492585.Bipol.Coagulation electrode part no.8622131 batch number 1496850.Snare electrode bipol.Part no.8623022 batch no.1357219.30° optics part no.8654422 serial number (b)(4).Permanent irrigation rotation outer shaft 26ch item no.8655374 batch number 1444764.Basic resection shaft art.No.86553841 batch number 1126078.The rf generator used was a erbe vio 300 d sn: (b)(4).Additional information about the generator's rf cables and power settings is not available.Exam: 30° optic part no.8654422 serial no.(b)(4): the condition of the 30° optic is as good as new and there are no signs of damage.In particular, there is no evidence of thermal damage in the area of the window at the distal end of the endoscope, which could have been caused by rf effects.2x 8680.204 working element active bipo 0/12/30° batch number 1495009 the working elements are in good condition and show no thermal damage in the area of the electrode guide.On the working element used in the case, article 8680.204, an hf test was carried out in the laboratory with the following test parameters: rated voltage according to the instructions for use (ifu): bipolar 2kv test voltage against breakdown: 3kv.Test result: no electrical breakdown, working element within specification.Continuous irrigation rotational outer shaft 26ch part no.8655374 batch number and 1444764 basic resection shaft part no.86553841 batch number 1126078.The distal ceramic sleeve shows cracks.The sheath system is slightly bent in the middle, the inner and outer shaft can still be mounted via the rotatable interface.4x bipol.Coagulation electrode art.No.8622131 batch number 1492585, bipol.Coagulation electrode art.No.8622131 batch number 1496850 and loop electrode bipol.Art.No.8623022 batch number 1357219, 2xcoagulation electrodes 8623022 all of the returned biplar cutting electrodes 8622.131 and monopolar cutting electrodes 8242.141 show no optical damage.One of the coagulation electrodes 8623022 shows a slight thermal influence on the distal application part.An electrical breakdown test of the electrode did not reveal any defects.(hf dielectric strength according to iec 60601-2-2 with 2.4kv).A test for electrical continuity also revealed no abnormalities.The products are therefore fully functional and meet the specifications.The electrodes on hand cannot be associated with the incident listed in the damage report, as none of the electrodes exhibits any damage described by the user.The evaluation is therefore based only on the information provided in the customer's incident report.When using hf current, there are system-related signs of aging on the application part (in this case the wire frame).This wear is dependent on many factors such as type of hf generator, setting of the hf generator, tissue contact, cutting speed, etc.Excessive power settings on the hf generator can cause rapid wear even within one application, which ultimately leads to breakage of the applied part.The user is therefore advised in the operating instructions to keep the power setting low.In addition, a visual inspection must be carried out before each application.Corresponding risks are listed and evaluated in risk assessment 82-3.A final assessment cannot be made at present, since the exact parameters of the hf generator and the duration of use have not yet been made available.In addition, the damaged electrodes were not sent in for assessment.Design-related or manufacturing-related errors cannot be detected.The correct selection of the power and mode of the hf generator is an essential point in the application of bipolar resection.Results / conclusion of the richard wolf investigation: based on the investigations described above, it can be assumed that the incident described is a case of user error.A direct connection with our products is not apparent.In our opinion, the ga-d 342 instructions for use (chapters 7, 8 and 9) contain sufficient information on visual and functional checks.In several places in the instructions for use, reference is made to checks to be carried out.In the risk assessment b6 r02, possible risks with the corresponding extent of damage and the assumed probability of occurrence were considered and assessed as an acceptable risk.This assessment is still valid, even taking into account the current case.Both the production records and the complaint database of the work element were examined.Records do not indicate any production or batch defect.Rw gmbh considers this matter closed.However, in the event rw gmbh receives any additional information, a follow-up report will be submitted to fda.Rwmic is submitting the report on behalf of rw gmbh.

Event Description

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

• Brand Name: S-LINE
• Type of Device: WORKING ELEMENT ACTIVE BIPO 0/12/30°
• 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: 14166307
• MDR Text Key: 289729446
• Report Number: 9611102-2022-00016
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207042922
• UDI-Public: 04055207042922
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

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: 8680204
• Device Catalogue Number: 8680.204
• Device Lot Number: 1495009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1