MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/S-LINE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number 46222513

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

As soon as the current was applied, the device popped and broke.Once this happened, no longer able to use the resectoscope after this event occurred.The scope was taken out of service and sent to sterile processing department for repairs.

• Brand Name: SHARK/S-LINE
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): RICHARD WOLF GMBH; 353 corporate woods pkwy; vernon hills IL 60061
• MDR Report Key: 19078527
• MDR Text Key: 339807748
• Report Number: 19078527
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207050026
• UDI-Public: (01)04055207050026
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024,09/20/2023

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: 46222513
• Device Catalogue Number: 4622.2513
• Device Lot Number: 4500356209
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Race: White