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 04/11/2024

Event Type  Injury  

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.

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).

Manufacturer Narrative

This mdr is created to correct section b3 from the initial report submitted.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id:(b)(4).

Manufacturer Narrative

Additional information is provided in section b5 and d9.The item in question was returned to the manufacturer.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

Additional information was provided stating that the burnt was discovered some days after the surgery, when the patient came back to the doctor complaining of pain.During a cystoscopy, doctor discovered the burnt in the urethra.The patient remained hospitalized and they had to practice a second surgery to try to rebuild and cure the urethra.After the failure, they had to perform an emergency cystectomy.The patient will have to stay in the hospital for 30 days at least.

• 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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 19110492
• MDR Text Key: 340228211
• Report Number: 9610617-2024-00105
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551378793
• UDI-Public: 4048551378793
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K171717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization