MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR; ENDOSCOPIC ELECTROSURGICAL ELECTRODE

Model Number 011160-10

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2023

Event Type  Injury  

Event Description

It was reported that the action of resecting is causing secondary injury due to rubbing of the return plate.Additional patient information is not available.

Manufacturer Narrative

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: ELECTRODE, BIPOLAR
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 16568020
• MDR Text Key: 311556019
• Report Number: 2020550-2023-00060
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/15/2023,03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other