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

Model Number 46221333

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2021

Event Type  malfunction  

Event Description

Using the large loop bipolar, upon taking the loop out of the patient realized that the loop became dislodged and was in the patient.Surgeon was able to locate and extract the loop from the patient.Schneide-elektrode bipo 22ch 12/30.Cutting electrode bipo 22fr 12/30.Lot 1445943.

• 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: 12664401
• MDR Text Key: 277397492
• Report Number: 12664401
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/14/2021,06/15/2021

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: No Information
• Device Model Number: 46221333
• Device Catalogue Number: 4622.1333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11680 DA