MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FLEX,INTUB.VIDEO ENDOSCOPE 3.0X51.5 SET; FLEXIBLE INTUBATION SCOPE

Model Number 11301ABXK

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/13/2020

Event Type  Injury  

Manufacturer Narrative

Return order was created but the scope is not yet retuned.According to the crna at the hospital, the patient is doing fine.

Event Description

The patient was undergoing a thoracic procedure and this scope was used to check tube placement.A piece of foreign body fell off and an ent surgeon was called in to remove the foreign body and the procedure was prolonged for 2 hours.

• Brand Name: FLEX,INTUB.VIDEO ENDOSCOPE 3.0X51.5 SET
• Type of Device: FLEXIBLE INTUBATION 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: 10038879
• MDR Text Key: 190473933
• Report Number: 9610617-2020-00058
• Device Sequence Number: 1
• Product Code: CAL
• UDI-Device Identifier: 04048551395875
• UDI-Public: 4048551395875
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2020

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 Operator: Health Professional
• Device Model Number: 11301ABXK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2017
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 4 DA