MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOFLATOR 50, W/INTEGRATED SCB MODULE; LAPAROSCOPIC GAS DISTENSION SYSTEM

Model Number UI500

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).

Event Description

Customer reported that during a procedure (approximately couple weeks before (b)(6) 2023), the endoflator 50 unit shut off by itself, and they had to restart the unit to move forward with the procedure.Customer stated that the procedure was completed without any patient impact.However they do not have further details regarding this procedure.

Manufacturer Narrative

Per evaluation findings by the manufacturer: the problem described by the customer could be reproduced.The problem occurs when the patient tube is placed on the instrument (nozzle 1.7mm) which is connected to the abdomen during the insufflation break.In this case, the flow only reaches a value of approx.1-3 l/min, which leads to the pressure being reached slowly or not at all (depending on the leakage).The problem can also occur if the leakage at the patient side is similar to the insufflation from the unit to the patient.The unit operates with a maximum insufflation pressure of 50mmhg, which means that the maximum flow is dependent on the instrument used.Therefore, if the instrument resistance becomes higher, the set flow will no longer be reached until the instrument resistance decreases.If the insufflation pressure isn't reached, the user is advised to replace the instrument, increase the pressure, check the plug connections and replace the tube / filter.Since the user has not performed all of these steps, it could be confirmed that the issue is based on a use error.Further, contamination was found in the high-pressure regulator.The substance of the contamination cannot be identified exactly.It could be detachment from the supply hose.This type of contamination can contaminate the sinter filter and cause the unit to malfunction.However, it seems that the contamination isn't responsible for the problem described by the customer.This issue is also based on a use error.Device was shipped to the customer on march-18-2022 under outbound delivery (b)(4) and had been in use for approx.12 months; device was never returned for service.

• Brand Name: ENDOFLATOR 50, W/INTEGRATED SCB MODULE
• Type of Device: LAPAROSCOPIC GAS DISTENSION SYSTEM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017
• MDR Report Key: 16815966
• MDR Text Key: 314086163
• Report Number: 9610617-2023-00077
• Device Sequence Number: 1
• Product Code: FCX
• UDI-Device Identifier: 04048551326657
• UDI-Public: 4048551326657
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UI500
• Device Catalogue Number: UI500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• Date Device Manufactured: 09/06/2020
• 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