MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TUBING SET, IRRIGATION, FC

Model Number 031524-01

Device Problem Device Handling Problem (3265)

Patient Problems Unspecified Vascular Problem (4441); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0074 corrective action 6.The user used the wrong tubing set for the planned hysteroscopic procedure.The user used 031524-01 tubing set, irrigation, fc; lot 200414.This tubing set in combination with the roller pump (endomat hamou) is not indicated for hysteroscopic procedures.The field of application is automatically selected when the correct tubing cartridge for the respective field of application is inserted.The device determines the intended field of application from the different "encodings" of the tubing cartridge and then automatically selects the appropriate operating parameters.The selected indication is visible on the screen of the device.The label of the tubing set contains the field of applications.The related ifu contains a warning to make sure to use cartridges only for applications specified on their packaging.The root cause is deemed as use error and not related to a device failure.The event is filed under internal karl storz complaint id (b)(4).

Event Description

It was reported that there was event with a tubing set, irrigation, fc.According to the information received a hysteroscopy was performed in which the hamou endomat scb (roller pump) was allegedly equipped with the wrong cassette tubing set.Therefore, the device ran with the pressure and flow parameters of the laparoscopy program.As a result, the patient experienced a severe tur syndrome.The patient was subsequently in intensive care for a longer period of time, but survived the incident.Additional patient information is not available.

• Brand Name: TUBING SET, IRRIGATION, FC
• Type of Device: TUBING SET, IRRIGATION, FC
• 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
• MDR Report Key: 17210129
• MDR Text Key: 317945664
• Report Number: 9610617-2023-00820
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K936231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/19/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 031524-01
• Device Catalogue Number: 031524-01
• Device Lot Number: 200414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 26331120-1 HAMOU ENDOMAT SCB, SN: (B)(6)
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention