MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOFLATOR 50; LAPAROSCOPIC INSUFFLATOR

Model Number UI500

Device Problem Unintended Electrical Shock (4018)

Patient Problems Electric Shock (2554); Insufficient Information (4580)

Event Date 09/28/2023

Event Type  malfunction  

Event Description

It was reported that it happened during the installation of the insufflator.In the moment to connect the insufflator filter 031122-01 the equipment gave an electric shock to the operating room assistant.

Manufacturer Narrative

The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id:(b)(4).

Event Description

On friday (b)(6) 2023 the delegate of the area came in person to the hospital to know more and the supervisor told him that the assistant is on medical leave since he says that he has no strength in the arm, paresthesia and swollen hand.On monday (b)(6) 2023 the delegate saw the chief of surgery service and told her that she had spoken with the assistant and remained the same.They had to do medical tests.

Manufacturer Narrative

Additional information is provided in section b5.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

The product was returned on 2023-10-25.The investigation of the product was completed on 2024-01-19.The problem described by the customer cannot be reproduced.The high voltage and electrical safety test showed that the electric shock was not caused by the insufflator (ui500).The device has been fully tested and works perfectly.The overvoltage must have another cause, which cannot be verified by inspecting the endoflator.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ENDOFLATOR 50
• Type of Device: LAPAROSCOPIC INSUFFLATOR
• 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: 18066711
• MDR Text Key: 327304433
• Report Number: 9610617-2023-00348
• Device Sequence Number: 1
• Product Code: FCX
• UDI-Device Identifier: 04048551326657
• UDI-Public: 4048551326657
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K161554
• 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,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UI500
• Device Catalogue Number: UI500
• Device Lot Number: WO10857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other