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

Model Number	46221313US
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Richard wolf medical instruments corporation (rwmic) received a medsun report: (b)(4), regarding an issue with a cutting electrode bipo 24fr 12/30°, part id: 46221313us, lot# 51018536.According to the medsun report, "provider noted issues with foot pedal for erbe not charging electrode, then would heat suddenly.The tech noted that element burned "white hot".When the lens cracked, scope set up was removed.The tech needed a kelly clamp to unseat electrode from resectoscope.Patient experienced aggressive bilateral leg movements during loop cautery, requiring more sedation.Tech noted what appeared to be metal flush out of patient during procedure and asked provider; provider believed it may have been from uroclips that were being removed during procedure.Once removed, uroclips appeared to be completely intact." original intended procedure: cystoscopy with transurethral prostatectomy, cystoscopy litholapaxy.
Additional Manufacturer Narrative
The provider claimed that the foot pedal for erbe, model vio 300d (non-richard wolf device), failed to charge and inadvertently produced high temperature that caused overheating and resulted into melting of the electrode, cutting electrode bipo 24fr 12/30°, 46221313us (richard wolf device).The malfunction occurred during the cystoscopy with transurethral prostatectomy (turp) and cystoscopy litholapaxy procedure.The event was likely caused by the foot pedal for erbe, model vio 300d.Richard wolf consider this matter as "reportable malfunction".
Additional Manufacturer Narrative
This follow-up report is in response to a request received by richard wolf gmbh from a fda (mdr data system team) regarding a related report information that was not included in the corresponding block h10 of medwatch form 3500a.Corrected information: h10 new information: b4, g3, g6 (follow-up number), and h2.

• Brand Name: SHARK/S-LINE
• Common Device Name: CUTTING ELECTRODE BIPO 24FR 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods parkway,; vernon hills IL 60061
• Manufacturer Contact: pforzheimer strasse 32; knittlingen, germany 75438
• MDR Report Key: 20358712
• Report Number: 1418479-2024-00007
• Device Sequence Number: 7283980
• Product Code: FAS
• UDI-Device Identifier: 04055207066027
• UDI-Public: 04055207066027
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: 46221313US
• Device Catalogue Number: 46221313US
• Device Lot Number: 51018536
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ERBE, MODEL VIO 300D.(NON-RICHARD WOLF DEVICE).
• Patient Age: 59 YR
• Patient Sex: Male