MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/S-LINE; BIVAP ELECTRODE BIPO 24-26FR 12/30°

Model Number	46300243
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the complaint is currently in progress.A follow up report will be submitted after the device evaluation has been completed and/or additional information become available.Rwmic is submitting this report on behalf of richard wolf (b)(4).
Event or Problem Description
On december 14, 2020 richard wolf (b)(4) was informed by rw (b)(4) about an adverse event.After about 45 minutes of vaporisation with the disposable electrode, the button suddenly detached from the electrode and the broken-off part was lost in the bladder.After a painstaking search, the 2 mm button was found in the bladder and finally flushed out.The user needed about 20 minutes for recovery.
Additional Manufacturer Narrative
The present 46300243 bivap electrode bipo 24-26fr 12/30° from the batch 21002383 was checked in the responsible technical department.The 46300243 bivap electrode bipo 24-26fr 12/30° from the lot 21002383 was produced on 29/04/2020.The lot 21002383 consists of 41 bivap electrodes bipo 24-26fr 12/30°.To the customer 2 pak of 46300243 bivap electrode bipo 24-26fr 12/30° were delivered on 12/11/2020.There have been no further complaints from lot 21002383 so far.Due to the detected defects / damages at the 46300243 bivap electrode bipo 24-26fr 12/30° from the lot 21002383 we assume increased wear and tear during use.A product or manufacturing defect could not be detected.The instruction for use ga342 s-line saline resectoscope instructions for use explicitly refer to this type of wear and tear.Chapter 7.2.4 hf application 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.Possible hazards were taken into account in the risk assesment bb2-3 rev 05 with the corresponding extent of damage and probabilty of occurance and assessed with an acceptable risk.This assessment is still valid even taking into acoun the current case.Richard wolf gmbh (rwgmbh) considers this matter closed.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation (rwmic) submitting report on behalf of rwgmbh report on behalf of rwgmbh.
Event or Problem Description
This follow up report is to provide the complaint investigation.The full description of the findings is provided in the section h10 of this report.

• Brand Name: SHARK/S-LINE
• Common Device Name: BIVAP ELECTRODE BIPO 24-26FR 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11149120
• Report Number: 9611102-2021-00001
• Device Sequence Number: 3637579
• Product Code: JOS
• UDI-Device Identifier: 04055207048948
• UDI-Public: 04055207048948
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 46300243
• Device Catalogue Number: 46300243
• Device Lot Number: 21002383
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other