MAUDE Adverse Event Report: RICHARD WOLF GMBH S-CWE CUTTING ELECTRODE; ELECTROSURGICAL, CUTTING, COAGULATION, ACCESSORIES

Model Number 4622.1313

Device Problems Break (1069); Component Missing (2306)

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

Event Date 07/17/2019

Event Type  Injury  

Event Description

Electrocautery loop broke during procedure unable to determine if all pieces were still present.Surgeon did a visual inspection to examine the entry and to locate any missing pieces.None wer found or visualized.

• Brand Name: S-CWE CUTTING ELECTRODE
• Type of Device: ELECTROSURGICAL, CUTTING, COAGULATION, ACCESSORIES
• Manufacturer (Section D): RICHARD WOLF GMBH; knittlingen ; GM
• MDR Report Key: 8866110
• MDR Text Key: 153562893
• Report Number: MW5088816
• Device Sequence Number: 1
• Product Code: GEI
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: 4622.1313
• Device Lot Number: 51015519
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR