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

Model Number 26331120-1

Device Problems Use of Incorrect Control/Treatment Settings (1126); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/08/2023

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that during an operative hysteroscopy for myomectomy.Passage of a 3l bag of saline induced poor recovery despite verified settings and increased aspirations.Despite verified settings and increased aspirations, the procedure was aborted.Clinical consequences: poor cavity distension, poor saline recovery, inter-abdominal fluid passage (2l).No death or (unanticipated) serious deterioration in state of health reported.

Manufacturer Narrative

The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

Result of investigation: the hamou endomat doesn't show any defect by the test of the verification engineer.Therefore, the most probable root cause is the wrongly set pressure (too high) to increase the uterus cavity which leads to tur syndrome.This is a well-known side effect of this specific procedure (myomectomy).The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HAMOU ENDOMAT SCB W/INTEGRATED 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: 18221326
• MDR Text Key: 329163906
• Report Number: 9610617-2023-00383
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other