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

Model Number 26331120-1

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/08/2023

Event Type  Injury  

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 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).

• 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
• MDR Report Key: 18221325
• MDR Text Key: 329163900
• Report Number: 2020550-2023-00383
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other