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

Model Number 10973HD

Device Problems Device Handling Problem (3265); Sharp Edges (4013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2023

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, one other similar case has been found.The manufacture continues to review and investigate.

Event 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.

Manufacturer Narrative

"health effect- impact code: appropriate term/code not available-surgery aborted".

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
• Type of Device: 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
• MDR Text Key: 314863605
• Report Number: 9610617-2023-00096
• Device Sequence Number: 1
• Product Code: EWY
• UDI-Device Identifier: 04048551425718
• UDI-Public: 4048551425718
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213194
• 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,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• 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