MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UH400 AUTOCON® III 400; ELECTROSURGICAL UNIT

Model Number UH400U

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned and will be forwarded to the manufacturing site in germany for evaluation.This event is filed under internal complaint id (b)(4).

Event Description

Customer reported that three times during one case and two times during another the generator just stopped working.The touch screen was frozen and was not responsive and the foot pedal did not activate the generator.System was shut down and restarted; it worked and then froze again.The procedures were completed using a backup generator.There was no negative patient impact.This report represents the second of the two cases.

Manufacturer Narrative

Per manufacturer evaluation findings: based on our initial investigation: by reviewing the similar complaint there is no indication for an increase/ trend of the reported issue.Customer complaint detected: yes; during test operation, the device "froze" without warning and operation was no longer possible.After switching off and on again, the device worked again.No relevant fault entries are recorded in the device's fault memory.Defects found: front unit defective ("freezes" sporadically, no operation of the device possible anymore).Conclusion and root cause determination: front panel module defective.Electronics defect.

• Brand Name: UH400 AUTOCON® III 400
• Type of Device: ELECTROSURGICAL UNIT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15946954
• MDR Text Key: 305521707
• Report Number: 9610617-2022-00330
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551378809
• UDI-Public: 04048551378809
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K171717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

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: UH400U
• Device Catalogue Number: UH400U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male