MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OPTITHERM; HEATING ELEMENT USED WITH THERMOFLATOR

Model Number 20432030

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The subject optitherm device was in use with a thermoflator, model number (b)(4), serial number (b)(4).The affected devices have been locked by the customer.The investigation is pending.

Event Description

As per a manufacturer incident report we received from the factory in (b)(6): the "optitherm" accessory, which was intended for preheating the gas to be insufflated has overheated far beyond the intended alarm limit value of 41 °c.This situation was not detected by the main unit.This circumstance was not detected by the main unit, so no alarm was triggered.Due to the direct skin contact, a large burn corresponding to the size of the housing burn occurred.Two devices were involved (optitherm and thermoflator).This report is for device 1 (optitherm).(mfr's.Internal complaint (b)(4)).

Manufacturer Narrative

Since the devices were locked by the customer, a physical investigation could not be performed.Based on the investigation report (dated 2021-12-17), the most probable root cause is a defect of the heat exchanger.It is probable that the plug of the gas heater was twisted due to mechanical stress, which could have led to the reported failure.If a physical investigation is possible, a revised report will be submitted.

• Brand Name: OPTITHERM
• Type of Device: HEATING ELEMENT USED WITH THERMOFLATOR
• 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 avenue; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 12642687
• MDR Text Key: 281269491
• Report Number: 9610617-2021-00068
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04048551068663
• UDI-Public: 4048551068663
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K955073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2019
• 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