MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INSUFFLATION GAS CONDITIONING SYSTEM; OPTITHERM HEATING ELEMENT

Model Number	20432030
Medical Device Problem Codes	Temperature Problem (3022); Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that during a surgery, the heating element (optitherm 20432030) burned the patient's skin.The heating element was connected to the thermoflator and probably overheated.
Additional Manufacturer Narrative
The investigation of the product was completed on 2024-01-09.The optitherm heating element and the thermoflator were inspected.The thermoflator is working properly, no defect was found regarding the reported issue.The optitherm heating element was also checked.It was found that the lemo connector at the end had been opened by the customer and reassembled incorrectly (the pins were twisted after reassembly).The faulty behavior of the optitherm heater described by the customer could be reproduced if the lemo plug on the optitherm is plugged into the device with only one pin counterclockwise.The heater then heats continuously and becomes very hot after a short time, which can lead to skin burns.An inquiry to the lemo company also confirmed that the inside of the returned lemo plug is not an original part and that this can lead to incorrect assembly after opening.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INSUFFLATION GAS CONDITIONING SYSTEM
• Common Device Name: OPTITHERM HEATING ELEMENT
• 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: 17887261
• Report Number: 9610617-2023-00276
• Device Sequence Number: 15276143
• Product Code: HIF
• UDI-Device Identifier: 04048551068663
• UDI-Public: 4048551068663
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K955073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: 20432030
• Device Catalogue Number: 20432030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown