MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FLEX. INTUBATION VIDEO SCOPE, 5.5 X 65CM; INTUBATION FLEXIBLE VIDEO SCOPE

Model Number	11303BNX
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has not responded to kst attempts to gather further information.The product has not returned for evaluation at this time.
Event or Problem Description
Per the factory in (b)(6), allegedly there was an event that an emergency video bronchoscopy was being performed due to obstructed airways (acute bleeding).The screen went black/ failed during the examination.A replacement had to be found promptly.Replacement of the medical device was done.The coagel was sucked.
Additional Manufacturer Narrative
Data in section h6 have been corrected to match the evaluation findings.
Additional Manufacturer Narrative
The endoscope has been sent in without information about an incident - during inspection, we were not able to detect any malfunction at all.It shows signs of use, but is full functionable.

• Brand Name: FLEX. INTUBATION VIDEO SCOPE, 5.5 X 65CM
• Common Device Name: INTUBATION FLEXIBLE VIDEO SCOPE
• 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: susie chen ; 2151 east grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 9869246
• Report Number: 9610617-2020-00038
• Device Sequence Number: 3752695
• Product Code: CAL
• UDI-Device Identifier: 04048551421598
• UDI-Public: 4048551421598
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2022

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
• Device Model Number: 11303BNX
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/10/2020; 08/11/2022
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 08/09/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2018
• 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
• Patient Sex: Unknown