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

Model Number	10973HD
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(4): as reported: "due to a sharp edge at the tip of the scope, the bronchus of the patient was ripped upon introduction of the scope, damage to bronchus had to be sutured/repaired" (manufacturer's internal complaint # (b)(4)).
Additional 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).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.

• Brand Name: VIDEO MEDIASTINOSCOPE
• Common Device Name: 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: 13052545
• Report Number: 9610617-2021-00092
• Device Sequence Number: 11826217
• Product Code: EWY
• UDI-Device Identifier: 04048551425718
• UDI-Public: 4048551425718
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10973HD
• Device Catalogue Number: 10973HD
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown