MAUDE Adverse Event Report: KARL STORZ SE & CO. KG VIDEO MEDIASTINOSCOPE; RIGID MEDIASTINOSCOPE

Model Number 10973HD

Device Problem Sharp Edges (4013)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Manufacturer Narrative

Compared to the predicate device, the current device has a changed design on the device tip.As the tip is chamfered according to specification, the issue was therefore found to be a specification issue and design related.Karl storz decided to recall all affected products - refer to internal fsca reference # (b)(4).Note: none of the devices affected by the recall have been distributed in the u.S.At the time of the occurrence of the adverse event and the initiation of the recall, the device has not been cleared by the fda.This adverse event is now reported retrospectively only because it was requested during fdas review of submission k213194.

Event Description

As per a manufacturer incident report we received from the factory in (b)(6): as reported, "two insertions of the mediastinoscope each resulted in shearing of a lower thyroid vein with severe blood loss." (manufacturer's internal complaint #(b)(4)).

• Brand Name: VIDEO MEDIASTINOSCOPE
• Type of Device: RIGID MEDIASTINOSCOPE
• 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 ; 13803 n. promenade blvd.; stafford, TX 77477
• MDR Report Key: 13052548
• MDR Text Key: 282561340
• Report Number: 9610617-2021-00093
• Device Sequence Number: 1
• Product Code: EWY
• UDI-Device Identifier: 04048551425718
• UDI-Public: 4048551425718
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10973HD
• Device Catalogue Number: 10973HD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention