MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG CUTTING LOOP, BIPOLAR; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number 27040GP130-S

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2021

Event Type  malfunction  

Event Description

A bipolar loop broke while being used by the doctor in a transurethral resection of bladder tumor case.The doctor realized what had happened and the supply was replaced, making sure that all pieces were collected and not in the patient's bladder.Manufacturer was notified and will send device to manufacturer.Maude search shows similar events in 2021 and 2020.

• Brand Name: CUTTING LOOP, BIPOLAR
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): KARL STORZ GMBH CO. KG; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 13009766
• MDR Text Key: 282269435
• Report Number: 13009766
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/30/2021

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: Health Professional
• Device Model Number: 27040GP130-S
• Device Lot Number: 37DA1609
• 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: 11/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other