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

Model Number 11303BNX

Device Problem No Display/Image (1183)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  malfunction  

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 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.

Manufacturer Narrative

Data in section h6 have been corrected to match the evaluation findings.

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
• Type of Device: 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
• MDR Text Key: 188080632
• Report Number: 9610617-2020-00038
• Device Sequence Number: 1
• Product Code: CAL
• UDI-Device Identifier: 04048551421598
• UDI-Public: 4048551421598
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 03/10/2020; 08/11/2022
• Supplement Dates FDA Received: 08/09/2022; 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1