MAUDE Adverse Event Report: KARL STORZ SE & CO. KG AUTOCON III 400 HIGH END, 220-240V

Model Number UH400E

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Pain (1994)

Event Date 03/10/2022

Event Type  Injury  

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).

Event Description

It was reported that "during the surgery there were no problems, although days later the patient reported pain, and upon examination, a burn was observed in the urethra.A reintervention is necessary, which entails hospitalization".Since a burn was observed and reintervention with additionally hospitalization was necessary, the case is deemed as reportable.

• Brand Name: AUTOCON III 400 HIGH END, 220-240V
• Type of Device: AUTOCON
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 19105723
• MDR Text Key: 340157973
• Report Number: 2020550-2024-00105
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551378793
• UDI-Public: 4048551378793
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UH400E
• Device Catalogue Number: UH400E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/11/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization