MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENT CORP. RICHARD WOLF SCHNEIDE-ELECTRODE BIPO 26CH CUTTING ELECTRODE; ELECTRODE, ELECTROSURGICAL

Model Number 4624.1313

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2019

Event Type  Injury  

Event Description

Loop electrode used for turp procedure broke off in pt during use.Surgeon retrieved broken loop and removed from pt.Fda safety report id# (b)(4).

• Brand Name: RICHARD WOLF SCHNEIDE-ELECTRODE BIPO 26CH CUTTING ELECTRODE
• Type of Device: ELECTRODE, ELECTROSURGICAL
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENT CORP.
• MDR Report Key: 9506192
• MDR Text Key: 172475834
• Report Number: MW5091826
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/18/2019

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 Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 4624.1313
• Device Lot Number: 4500265840
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR
• Patient Weight: 74