MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK / S-LINE; CUTTING ELECTRODE BIPO 24FR 12/30°

Model Number 4622.1313

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)

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

Event Date 06/16/2022

Event Type  malfunction  

Event Description

Richard wolf gmbh complaint reference (b)(4).Richard wolf in knittlingen (manufacturer) was informed about the user report to the spanish competent authority via distributor.Description of incident/claim: the distal part of the cutting electrode loosens spontaneously at the beginning of the surgery.The user then searched for the broken electrode fragment with a cystoscope.The fragment was recovered and the treatment was completed with a new electrode.Consequences for the patient were described as a prolonged operating time.No information was given on the duration of the delay.This case was reported by the user to the (b)(6) authorities.Rwgmbh awareness date, (b)(6) 2022.

Manufacturer Narrative

Rwmic is submitting this report on behalf of the manufacturer richard wolf gmbh.The 4622.1313 cutting electrode bipo 24fr 12/30° has been in the programme since 29.09.2006.The cutting electrodes with the batch 1489304 were booked in stock on 10.02.2022 with a batch size of 58 packs.A total of 46 packs from the affected batch were delivered to the distributor in spain on 07.04.2022.1 pack contains 3 cutting electrodes.In the meantime, the distributor has apparently made enquiries with further customers about the affected batch, but so far it is an isolated incident at the alicante hospital which has not been reproduced with other electrodes corresponding to the same reference and batch.Richard wolf gmbh is also not aware of any complaints regarding this batch.According to the production record, no indications of product or production defects are apparent.The instrument has not yet been returned for examination.As soon as the examination is completed, rw gmbh will send a follow-up report.

Manufacturer Narrative

Richard wolf medical instruments (rwmic) is submitting this mdr on behalf of the device manufacturer, rw gmbh.Follow-up report #1 is to provide fda with the device history and production record regarding this mdr.The following fields have new information: h6 (type of investigation, investigation findings, and investigation conclusion).Due to the fact that the affected electrode cannot be examined, no conclusions can be made about the defect and possible root cause.The device history record and production record show no abnormalities.So far, no other cutting electrodes from the affected lot: 1489304 have been returned to richard wolf gmbh.The period 01/01/2019 to 07/19/2022 was subjected to a closer examination of the complaints database.During this period a total of (b)(4) packs of 4622.1313 cutting electrode bipo 24fr 12/30° were sold.2 similar complaints ("distal loop broke") are known for this model.But in both cases, the relevant electrodes were also not available for examination.One of the two complaints was reported to fda due to parts remaining in the patient.(mfr report #1418479-2021-00046, (b)(4)).The associated ifu ga-d342 / en / 2021-03 v16.0 / pk20-0295 / contains the following instructions for the handling of electrodes: 2 intended use: 2.5 electrodes.For ablating, severing, cutting, coagulating, and vaporizing soft tissue.The electrodes differ in terms of use / reprocessing / reusability: 1.Multiple use electrodes, reprocessable.Use: bipolar.Identifying feature: the product numbers begin with "8", for example: 8622131.2.Disposable electrodes, sterile.Use: bipolar.Identifying feature: the product numbers begin with "4", for example: 4622.1313.7 use.Caution! the products have only limited strength! exerting 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.7.2.4 hf application: warning: there is a risk of injury if the hf instrument is not in the operator's field of vision! unintentional tissue damage, as well as damage to the distal end of the endoscope, and to the instrument parts is possible.Use hf instruments within the given specifications (dielectric strength, operating mode).Do not activate hf instruments until the hf current-carrying part appears fully in the field of view of the endoscope and the intended application area is contacted.Warning: risk of injury in the sphincter / cervical region! if the power settings exceed the value recommended by the hf device manufacturer, there is an increased risk of thermal damage and abrasion as well as a risk of breakage of the electrode bracket (wire).Greater irritation of the obturator nerve is also possible in this case, and the resulting twitching may promote unintentional perforation.Set power settings according to the value specified by the hf device manufacturer.The depth effect (necrosis) is about 0.5 to 2 mm, depending on the power / mode of the electrode.Therefore, be especially careful near the sphincter / cervix and use the lowest possible hf power.A dark brown coloration or carbonization of the tissue indicates excessive power.Note: excessive power setting may lead to significantly higher electrode wear.To determine the optimum power setting, we recommend starting with a low power setting.8 checks.Warning: injuries due to damaged or incomplete products! injuries to the patient, user, and others are possible.Do not use the products if they are damaged and incomplete or have loose parts.Run through the checks before and after each use.Attention: send in damaged or incomplete products together with any loose parts for repair.Repair only by authorized experts.In the risk assessment b2-3 reusable resecting electrodes rev.04, production-related, handling and design hazards with regard to a functional impairment as well as risks from a product that cannot be used were considered with the corresponding extent of damage and the assumed probability of occurrence and evaluated with an acceptable risk.Hazards: hazard due to non-usable product.Causes: handling-related -> product damage.Harms: extension of the procedure.Since no new risks have arisen from the investigation of the current complaint case, the risk assessment remains valid in view of the facts described.As a conclusion, no detailed assessment can be made for this incident due to the electrode is not available anymore for investigations.The product and complaint data do not reveal any abnormalities, so no further action is considered necessary.Richard wolf medical instruments (rwmic) is submitting this mdr behalf of the device manufacturer, rw gmbh.Rw considers this matter closed.However, if a new information is available, rw will submit a follow-up report.

Event Description

Richard wolf gmbh complaint reference: (b)(4).The purpose of this submission is to provide additional information as well as, the device history and production record.The distributor informed that the affected electrode was disposed of by the hospital in the operating room and therefore the electrode cannot be sent in for examination.Furthermore, the distributor provided additional information regarding the prolonged operating time and the generator settings: "the hospital has not specified the extra time that the intervention lasted, although they estimate that it was between 30 and 40 minutes.The generator settings were apparently adjusted to normal parameters for prostate resection surgeries.".

• Brand Name: SHARK / S-LINE
• Type of Device: CUTTING ELECTRODE BIPO 24FR 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; 75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer Contact: philipp schmidt ; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 15184497
• MDR Text Key: 305091563
• Report Number: 9611102-2022-00038
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207048856
• UDI-Public: 04055207048856
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

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 Model Number: 4622.1313
• Device Catalogue Number: 4622.1313
• Device Lot Number: 1489304
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention