MAUDE Adverse Event Report: KARL STORZ SE & CO. KG VIDEO MEDIASTINOSCOPE; LERUT VIDEO MEDIASTINOSCOPE,UNINTERRUPTED SIDE SLIT CHNL

Model Number 10970MVS

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 03/28/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation on-going.Product currently will stay at the facility.Should the product be sent in later with additional information/investigation results a supplemental medwatch will be submitted unsolicited.The event is filed under internal karl storz complaint id (b)(4).As of today, there are no similar device report or a report due to similar complaint assessment.

Event Description

It was reported that there was event with a 10970mvs video mediastinoscope.During assembly of the three-part mediastinoscope, the scope broke off from its base.Surgery was canceled.No patient injury, patient under anesthesia, but no incision made.

Manufacturer Narrative

Per manufacture: according to the customer, the handle broke off during assembly before the operation of the mediastinoscope.The scheduled surgery was canceled.There was no patient damage, the operation was not started.The article was 17 years old at the time of the incident (28.03.2023).A possible cause of the damage may be due to the high age and the resulting multiple reprocessing and surgical applications.A detailed examination of the item cannot be carried out, as the item will not be sent back according the event is filed under internal karl storz complaint id (b)(4).

• Brand Name: VIDEO MEDIASTINOSCOPE
• Type of Device: LERUT VIDEO MEDIASTINOSCOPE,UNINTERRUPTED SIDE SLIT CHNL
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 16826702
• MDR Text Key: 314126507
• Report Number: 9610617-2023-00086
• Device Sequence Number: 1
• Product Code: EWY
• UDI-Device Identifier: 04048551049778
• UDI-Public: 4048551049778
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10970MVS
• Device Catalogue Number: 10970MVS
• Device Lot Number: ID 3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 09/20/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2006
• 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