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

Model Number	26432020-1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unit in question was requested for return.The investigation is still pending.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6) : during insufflation, the patient had a cardiac arrest.The customer reported that the patient has recovered.(mfr's.Internal complaint # (b)(4)).
Additional Manufacturer Narrative
As per the final mir (ref.#(b)(4)) received from the factory in germany: the item in question was requested for return several times.Our french subsidairy informed us that the device won't be available for return since it is in use.This complaint is not reportable, because there is no correlation between the reported injury and the thermoflator.We will observe this case and provide a revised report if new information will become available.
Additional Manufacturer Narrative
As per revised final mir (ref.# (b)(4) received from the factory in germany: the serial number (b)(6) and manufacturing date (06th december 2018) of the thermoflator was added.The device had been sent to the after sales department of our french subsidiary in october 2021 for maintenance.At this time karl storz was not made aware of the reported event.Our french subsidiary has confirmed that the customer is not able to provide information regarding the logs of the device nor the device settings that were used in the or.Based on this very limited information a thorough investigation is not possible.We will observe this case and provide a revised report if new information will become available.
Additional Manufacturer Narrative
As per another revised final mir (ref.(b)(4) received from the factory in germany: the item in question was evaluated by a designated karl storz employee.According to the evaluation results, the control behavior shows no abnormalities even to the regulation becomes more coarse after proximality 10 minutes.The control regulates the pressure to an average of 9.7 mmhg.To exclude a product related malfunction, a long therm measurement test was performed.After 2.5 hours the device was restarted.After the restart, the device showed the error message "flow error".After allowing the device to cool down, the error disappeared.In conclusion, a product related malfunction could not be confirmed.There is no correlation between the reported injury and the thermoflator.We will observe this case and provide a revised report if new information will become available.

• Brand Name: THERMOFLATOR
• Common Device Name: INSUFLLATION DEVICE
• 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: 13289321
• Report Number: 9610617-2022-00014
• Device Sequence Number: 20011010
• Product Code: HIF
• UDI-Device Identifier: 04048551069264
• UDI-Public: 4048551069264
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup,Followup
• Report Date (Section B): 06/10/2022

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?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 03/15/2022; 04/14/2022; 06/09/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 03/24/2022; 05/10/2022; 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2018
• 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; Life Threatening
• Patient Sex: Unknown