MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEX. INTUBATION VIDEO SCOPE 5.5 X 65 CM

Model Number	11303BNXK
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that pieces of the sheath of the endoscope were found in the patient's trachea, removal was required using forceps.The sheath of the device didn't seem to have integrity issues when examined.Additional patient information is not available.
Additional Manufacturer Narrative
We recently researched the serial number history of this device and found that the device returned from an affiliated facility in october 2022.The reported issue for that return did not indicate that the scope was involved in a medical event; the problem as described for that return was "leak distal end".The evaluation findings at that time were as follows: external puncture in angle cover at distal threadwrap, causing leak.Epoxy bond failure in the shaft at adaptor.We reviewed the pictures from this evaluation and one picture shows a section of the angled cover is missing.Therefore, we believe that the pieces that were reported to have fallen into the patient's trachea most likely came from this missing section of the angle cover and we are therefore updating this report to reflect this evaluation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
This supplemental report is to include missing information that was not included in the last report.The damage to the product was caused by the lack of maintenance and care.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The purpose of this report is to correct section b3 to reflect the correct incident date of september 21, 2022, and not september 21, 2023 as reflected in the initial report.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FLEX. INTUBATION VIDEO SCOPE 5.5 X 65 CM
• Common Device Name: FLEX. INTUBATION VIDEO SCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 16336377
• Report Number: 1221826-2023-00025
• Device Sequence Number: 15157856
• Product Code: CAL
• UDI-Device Identifier: 04048551421598
• UDI-Public: 04048551421598
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/03/2023

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: 11303BNXK
• Device Catalogue Number: 11303BNXK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 02/03/2023; 02/03/2023; 05/03/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 02/14/2023; 03/10/2023; 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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