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

Model Number	20432030
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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)).
Additional 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
• Common Device Name: 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
• Report Number: 9610617-2021-00068
• Device Sequence Number: 19159788
• Product Code: HIF
• UDI-Device Identifier: 04048551068663
• UDI-Public: 4048551068663
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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