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

Model Number 20432030

Device Problems Temperature Problem (3022); Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 09/20/2023

Event Type  Injury  

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

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.

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
• Type of Device: 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
• MDR Text Key: 325122606
• Report Number: 9610617-2023-00276
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04048551068663
• UDI-Public: 4048551068663
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K955073
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other