MAUDE Adverse Event Report: KARL STORZ SE & CO. KG THERMOFLATOR; INSUFFLATION DEVICE

Model Number 26432020-1

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

Refer to medwatch report #9610617-2021-00068.

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 2 (thermoflator).(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 (b)(6) 2021), 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: THERMOFLATOR
• Type of Device: INSUFFLATION DEVICE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 12642608
• MDR Text Key: 281209769
• Report Number: 9610617-2021-00069
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• 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: 26432020-1
• Device Catalogue Number: 26432020-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other