MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HAMOU ENDOMAT SCB W/INTEGRATED SCB; SUCTION / IRRIGATION SYSTEM

Model Number 26331120-1

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2021

Event Type  Injury  

Manufacturer Narrative

The device is currently in transit to the manufacturer.The investigation is anticipated, but not yet begun.

Event Description

As per a manufacturer incident report we received from the factory in (b)(6): during hysteroscopy, the patient had an air embolism, caused in a sudden desaturation and a heart rhythm disorder.As a medical intervention, the patient had to be intubated.

Manufacturer Narrative

The device was sent back to the manufacturer.The investigation was performed on 2021-08-18.According to the results of the log files, no malfunction or non-conformity could be found.In addition, the device passed all functional tests as per factory specifications.The root cause of the air embolism is most likely that the tubing set was not primed prior to its usage.As written in the instructions for use (document id 96116041d, version 4.0, chapter 6.12), it is written that a functional check and the de-airing process must be performed prior to each application.

• Brand Name: HAMOU ENDOMAT SCB W/INTEGRATED SCB
• Type of Device: SUCTION / IRRIGATION SYSTEM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 12321071
• MDR Text Key: 266566990
• Report Number: 9610617-2021-00058
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K936231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26331120-1
• Device Catalogue Number: 26331120-1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention