MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ENDOMAT® SELECT; SURGICAL IRRIGATION / SUCTION SYSTEM

Model Number UP210

Device Problems Use of Device Problem (1670); Improper Flow or Infusion (2954)

Patient Problem Embolism/Embolus (4438)

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

As a preliminary result, it can be concluded that the customer used a software that was not intended for the described treatment.The manufacturer is waiting for further information regarding the incident.Further investigations will be planned as soon as more details are available.

Event Description

As per a manufacturer incident report we received from the factory in (b)(6): it was reported that the customer used an arthroscopy setup endoscope setup for a hysteroscopy.Since the arthroscopy software is not intended for this type of treatment, the customer provoked an embolism.According to customer's information, the patient has recovered completely.

Manufacturer Narrative

According to the investigation results, the wrong license was used (arthroscopy instead of hysteroscopy), where the flush volume and pressures have different limits.The irrigation pressure limit of the hysteroscopy software is 100 mmhg due to safety reasons.For this case, the most probable root cause is that the embolism was caused by a too high pressure.The customer will be informed about the misuse.

Manufacturer Narrative

This supplement report is filed to correct both the date of incident and the date report was received.

• Brand Name: ENDOMAT® SELECT
• Type of Device: SURGICAL IRRIGATION / SUCTION SYSTEM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 12460147
• MDR Text Key: 271034440
• Report Number: 9610617-2021-00065
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04048551376041
• UDI-Public: 4048551376041
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K201355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UP210
• Device Catalogue Number: UP210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female