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

Model Number 8622131

Device Problems Material Fragmentation (1261); Melted (1385)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2022

Event Type  malfunction  

Event Description

Richard wolf gmbh complaint reference number (b)(4).The user has reported the following: a tur bladder resection was planned.The loop melted immediately when the resection pedal was pressed.The rest of the loop (part of the arch) was removed, the rest were tiny balls which were evacuated with the help of a bubble syringe.The application was completed with a replacement electrode.Surgery time increased by 25 minutes.Rwgmbh awareness date, (b)(6) 2022.

Manufacturer Narrative

Richard wolf medical instruments corporation (rwmic) is submitting this report on behalf of rwgmbh.Rwgmbh considers this matter open.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.

Event Description

The purpose of this submission is to report the results of the device evaluation.See h10.Device evaluation: rwgmbh awareness date, 10-jan-2023.

Manufacturer Narrative

New information: b4, b5, g3, g6, h2, h3, h6 (clinical and impact code, type of investigation, investigation findings, investigation conclusions), h7, and h10.The incident questionnaire dated 02.09.2022 states the following: a tur bladder resection was planned.Immediately upon pressing the resection pedal (foot switch), the sling melted.Remainder of the sling (part of the arch) was removed, the rest consisted of tiny balls which were evacuated with a bladder syringe.Due to the incident, the operating time was extended by 25 minutes.The procedure was completed with a replacement electrode.Negative effects for the patient did not result.According to the user's description, the hf generator 2260 from r.Wolf (ref (b)(4)) was used.Information on the settings of the generator, the number of reprocessing cycles of the electrode and other products used in combination is not available.The cutting electrodes 8622131 have been in the programme since 2008.230 pc cutting electrodes 8622131 were booked into stock on 06/10/2021.The electrodes from lot 1487178 were fully sold in the period 05/11/2021 to 22/11/2021.As of 01.12.2022, no further electrode from lot 1487178 has been claimed.On 08.11.2021, 15 electrodes from lot 1487178 were delivered to this customer.In a current series of tests, the force required to move the guide tube was determined for 6 cutting electrodes from 4 lots.The force required for displacement was above the defined limit value for all electrodes.The application of a greater force by the user is considered improper handling.The following applicable warnings for this error are described in the instructions for use ga-d342 / en / 2021-03 v16.0 / pk20-0295: 7 use warning the products have only limited strength! exerting excessive force will cause damage, impair the function, and therefore endanger the patient.Always hold the cable by the plug when plugging and unplugging; never pull on the hf cable.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 risk of hf arcing! too small a distance between high-frequency current-carrying parts and other conductive parts, as well as significant heat generation, can lead to unintentional damage to the tissue and to damage of the ceramic on the sheath and on the endoscope.Activate high-frequency current-carrying parts of hf instruments only in the extended state (fig.23).In the event of hf arcing, replace the electrode immediately, check the endoscope for damage, and, if necessary, send in for repair to prevent consequential damage.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.Possible hazards due to thermal energy were considered in the risk assessment b2-3, rev.04 with the corresponding extent of damage and probability of occurrence.This assessment remains valid even under consideration of the new case.In summary, the information provided by the customer and the damage pattern suggest that improper handling has occurred (user error).In order to counteract this, the user is informed in the associated instructions for use about the checks to be carried out before and after each application.In addition, he is advised not to use any damaged products.The short-circuit could have been avoided by taking these instructions into account.Based on the above findings and the fact that there are no indications of a product or batch problem, no measures are considered necessary.

• Brand Name: SHARK/S-LINE
• Type of Device: CUTTING ELECTRODE BIPO 24FR 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 22; 75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 22; 75438 knittlingen, germany ; GM
• Manufacturer Contact: oliver ehrlich ; pforzheimer strasse 22; 75438 knittlingen, germany ; GM
• MDR Report Key: 15470477
• MDR Text Key: 300723104
• Report Number: 9611102-2022-00048
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207018019
• UDI-Public: 04055207018019
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8622131
• Device Catalogue Number: 8622131
• Device Lot Number: 1487178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other