MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HAMOU ENDOMAT SCB

Model Number 26331120-1

Device Problems Accessory Incompatible (1004); Misconnection (1399)

Patient Problem Embolism/Embolus (4438)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 22-0074 corrective action 6.Our analysis of the causes of this incident: the demonstration equipment endomat n.Hamou scb was sent on march 16 and was then picked up on april 7 by the service department of (b)(6)hospital.The equipment arrived in the form of a suitcase containing several items including sterile products, a set of tubes for laparoscopy and a set of tubes for hysteroscopy.The device was also sent together with documents and labels to clearly identify that this device is for demonstration purpose only as well as a sheet pointing the customer to the karl storz web page to examine the instructions for use of the product.However, the user used the tubing for laparoscopic application instead of hysteroscopy tubing for the anticipated hysteroscopic application.This is a user error because the set of tubes for laparoscopy and the set of tubes for hysteroscopy are clearly identifiable with clear labels.Also, there are multiple warnings in the instruction for use to check for the suitability of the product for the intended procedure prior to use.The event is filed under internal karl storz complaint id (b)(4).

Event Description

It was reported that there was event with a hamou endomat scb.According to the information received there was an observation of increased flow and volume when using endomat equipment for suction irrigation during hysteroscopy.The tubing used was laparoscopic tubing and not hysteroscopy tubing.Description of the impact on patient/user/others: occurrence of intraoperative embolism in the patient.But this has been treated and no current damages.Additional patient information is not available.

• Brand Name: HAMOU ENDOMAT SCB
• Type of Device: HAMOU ENDOMAT SCB
• 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: 17290678
• MDR Text Key: 318748142
• Report Number: 9610617-2023-00824
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/28/2023

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 Model Number: 26331120-1
• Device Catalogue Number: 26331120-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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