MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HD MEDIASTINOSCOPE; VIDEO MEDIASTINOSCOPE WITH CONTINUOUS LATERAL SLIT

Model Number	10973HD
Medical Device Problem Codes	Device Handling Problem (3265); Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Additional 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, one other similar case has been found.The manufacture continues to review and investigate.
Event or Problem Description
It was reported that there was event with a 10973hd video mediastinoscope.The surgeon complained that this hd version felt to sharp at the tip and complained about the angle at the distal portion of the scope.Surgeon felt there was a real risk of perforating the trachea.No patient injury, patient under anesthesia, but no incision made.
Additional Manufacturer Narrative
"health effect- impact code: appropriate term/code not available-surgery aborted".
Additional Manufacturer Narrative
Per manufacture findings: after a thorough examination of the mediastinoscope in our possession, the customer's information regarding the sharp tip / sharp working end cannot be confirmed.The working end is clearly blunt and evenly rounded.The imaging is clear and distinct with no discernible image impairments.The connector plug as well as the connecting cable are without defects.The customer's complaint cannot be substantiated.No production defect was found in the product.The mediastinoscope complies with the currently valid specifications the internal karlstorz complaint number is (b)(4).

• Brand Name: HD MEDIASTINOSCOPE
• Common Device Name: VIDEO MEDIASTINOSCOPE WITH CONTINUOUS LATERAL SLIT
• 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: 16885815
• Report Number: 9610617-2023-00096
• Device Sequence Number: 6312684
• Product Code: EWY
• UDI-Device Identifier: 04048551425718
• UDI-Public: 4048551425718
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K213194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 04/10/2023; 10/19/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 05/11/2023; 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown