MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/S-LINE; CUTTING ELECTRODE BIPO 22FR

Model Number	46221333
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This mdr is being submitted as part of a retrospective review of all 2016-2017 complaint files that rw mic is conducting.The complaint specialist determined a re-assessment of the mdr decision for this complaint was needed and that, this complaint.If a similar failure or malfunction were to occur with the same or similar device, could death, life threatening injury or life-threatening illness occur, an mdr should be filed.It was reported to richard wolf by the user facility that "electrode fell apart during surgery, loop broke lose on both sides.No patient injury." additional details: will the device be returned? yes (returned on (b)(4)).Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient 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? no.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? unknown.Trend analysis: 1/11/17: similar issues, waiting investigation results.No action taken at this time.(b)(4).3/21/17: appears to be facility related, no action taken at this time.(b)(4).History: on 1/11/17, (b)(4), determined that this was non-reportable: no injury, to patient or staff.Backup device readily available for use.Minimal delay, minimal risk to patient.Procedure completed as scheduled.On 12/7/2020, (b)(4), determined that "if a similar failure or malfunction were to occur with the same or similar device, could death, life threatening injury or life-threatening illness occur?" yes an mdr should be filed.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf (b)(4).Richard wolf medical instruments corporation is the importer of this device.The results of the device evaluation: product appearance: used.First time repair.Test method: visual means.Probable root cause: user handling.Conclusion: high voltage could cause the loop to break if used without fluid.Complaint deemed not valid.Action required: replace with new.(b)(4).Warning! danger of burns! hf bipolar connection cables (14) with defective / brittle insulation can lead to burns.Danger for user and patient! broken electrical cables, no matter whether the insulation is damaged or not, can cause a light arc and thus may burn the user or patient, or start a fire.Do not use and do not repair a defective hf bipolar connection cable (14).Replace a defective cable.The connection cable (14) must not be modified under any circumstances.Use the hf bipolar connection cables (14) only at a maximum recurring peak voltage, up to 1000 vp.6.2.3 irrigation fluid: caution! irrigation fluid can be electrically conductive! depending on the application the user must select a suitable irrigation fluid.Depending on the hf application, use the following irrigation fluids: z bipolar application: '0.9% nacl solution (saline) z monopolar application (only if required): 'no (saline) nacl solution 'the irrigation fluid must have a low conductivity (e.G.Glycine, purisole).Caution! danger of elevated temperatures when working without irrigation fluid! injuries to the mucous membrane due to excessive temperatures endanger the patient.Activate the electrode only while it is immersed in irrigation fluid and under continuous irrigation.Note! to facilitate the evacuation of air bubbles generated mainly during bipolar tissue ablation (coagulation/vaporization), we recommend using sheaths with distally straight or oblique sheath ends.Caution! careful if hf output power is incorrectly selected! injuries to 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 with regard to the corresponding indication.Caution! careful if the hf voltage / power is set too high! danger of injury resulting from damage to the electrode insulation! damaged insulation can cause leakage currents.Thermal damage to the patient and / or user are possible.Replace electrode.Caution! thermal damage may be caused if the vaporization electrode is permanently activated! high levels of heat or distal wear to the electrode insulation may be the result.When using the vaporization electrode, the following should be observed: 'no permanent activation of the vaporization electrode 'activation and pause phases should be implemented in the same way as when using a cutting electrode 'the vaporization electrode should only be activated when in contact with large areas of tissue note! excessive power settings can cause clearly increased electrode wear.We recommend starting at a lower power setting to determine the optimum power setting.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

• Brand Name: SHARK/S-LINE
• Common Device Name: CUTTING ELECTRODE BIPO 22FR
• 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: 13239669
• Report Number: 1418479-2022-00001
• Device Sequence Number: 4555285
• Product Code: FAS
• UDI-Device Identifier: 04055207048870
• UDI-Public: 04055207048870
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K060720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 46221333
• Device Catalogue Number: 4622.1333
• Device Lot Number: 51005314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN/NOT GIVEN
• Patient Sex: Unknown