MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BI-POLAR ELECTRODE

Model Number 011160-10

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 05/01/2021

Event Type  Injury  

Event Description

The reported event happened in (b)(6).It was reported that during a turp procedure, the doctor was unable to use three bipolar resectoscope loops.One side of the yellow guards pushed forward whenever the power cable was inserted into the storz working element.So that they were uneven and therefore stood proud on the screen and were unusable.Additionally, it was reported, that during the resection of the prostate by the surgeon, one of the side arms came off and the loop electrode broke and entered the bladder.A bladder biopsy was needed to retrieve the broken part of the loop electrode and to examine the bladder to ensure it was not perforated.No negative impact on the state of health was reported.Additional patient information is not available.

Manufacturer Narrative

Based on the description, most likely the bipolar electrodes got mechanically overloaded - this is the most common reason for failure in similar complaints.The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: BI-POLAR ELECTRODE
• Type of Device: BI-POLAR ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 16158894
• MDR Text Key: 307302615
• Report Number: 2020550-2023-00015
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2023,01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011160-10
• Device Catalogue Number: 011160-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/12/2023
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention