MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOMAT® SELECT; SURGICAL IRRIGATION / SUCTION SYSTEM

Model Number UP210

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Air Embolism (1697); Ischemic Heart Disease (2493)

Event Date 11/22/2021

Event Type  Injury  

Event Description

As per a manufacturer incident report we received from the factory in (b)(4): received incident description: "the patient is being treated today for a hysteroscopy operation under ga.The iade on duty informs the operators that the patient is desaturating.The surgeon asks if he should stop the procedure, the anesthesiologist takes stock of the situation.Mar reinforcement is requested to perform a cardiac ultrasound and request to stop the operative procedure.An air embolism is identified.The patient is technically treated, taken care of quickly, and the hyperbaric chamber is called in urgently.4:10 p.M.The patient is stabilized and the (b)(6) (medical emergency service) arrives for the transfer." (mfr's.Internal complaint # (b)(4)).

Manufacturer Narrative

The concerned medical device has been requested for investigation by the manufacturer, but so far the customer has refused to send the device back.Further information about the patient outcome has also been requested.

Manufacturer Narrative

The concerned medical device is not yet available for investigation by the manufacturer.

Event Description

Further information received about the consequences for the patient: "-(b)(6) 2021: ms t transfer via samu 15 in the hyperbaric chamber then in intensive care surgical for non-invasive ventilation - night from (b)(6): patient extubated in the night - (b)(6) 2021: mri performed, being interpreted because of the observation of hypotonia of the arm - suspicion of an ischemic heart problem - the anatomo-pathological sample is sent to the laboratory for analysis." (mfr's.Internal complaint (b)(4)).

Manufacturer Narrative

The concerned endomat select was inspected and tested.There are no visible damages on the device, and the tests also showed no malfunctions.The device was fully functional and it passed all tests.The log files of the endomat select were also evaluated.It is visible in the log files that on the date of the incident ((b)(6) 2021) the device detected a short overpressure state during the operation.This could potentially have occurred due to closing the irrigation inlet valve on the instrument, or a sudden pressure increase in the surgical area (e.G.Quickly applying physical pressure to the cavity).When the overpressure state was detected by the device it issued an alarm (acoustical and visual alarm).The overpressure was not caused by a fault/malfunction of the device.No other unexpected events were visible in the log file.The log file shows that the pressure of the endomat select had been set to 80mmhg before the procedure and this pressure setting was not increased on the device during the operation.Based on the investigation results it is concluded that the concerned device was not the cause for this incident.We are aware of one other case where an embolism occurred during operation in combination with the endomat select model (case in germany in 2021).However, in this case the information was given that the staff in the hospital used the arthroscopy software for a hysteroscopy procedure.Therefore, the root cause was that a wrong software was used for the hysteroscopy procedure.Since this was not the cause for this present incident, the case from germany is not considered as similar to this one.

Event Description

Per additional information for mir (b)(4) received from the manufacture: update on the current patient health status from the healthcare professional: "i have seen her recently for a medical consultation, and she was doing fine.We have discovered that she has diabetes but she is taking care of.".

• Brand Name: ENDOMAT® SELECT
• Type of Device: SURGICAL IRRIGATION / SUCTION SYSTEM
• 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: 12975621
• MDR Text Key: 282042731
• Report Number: 9610617-2021-00089
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04048551376041
• UDI-Public: 4048551376041
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201355
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2022

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
• Device Operator: Health Professional
• Device Model Number: UP210
• Device Catalogue Number: UP210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 11/25/2021; 05/03/2022
• Supplement Dates FDA Received: 01/11/2022; 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 53 YR
• Patient Sex: Female