MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIVE S 3.5X65, STERILE, FOR SINGLE USE,; FIVE S, LARYNGOSCOPE

Model Number 091361-06

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2023

Event Type  Injury  

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 Description

It was reported that the scope was used for an awake fibre-optic intubation the camera tip broke off and went missing during bronchoscopy.The bronchoscope was already in the trachea, but the et tube struggled to railroad through the mass lesion at the vocal cords.The scope was pulled back to confirm the position of the et tube, but the picture went blurry and did not clear with suctioning.The patient started to desaturate.The scope was retracted, and the ventilation was initiated.The scope was checked for completeness, and it was discovered that the camera tip was absent.After the procedure, the tip was found on the floor.The intubation was unsuccessfully, and a tracheostomy needs to be performed.The cause of the tracheostomy is unknown, but due to the steps taken and the additional treatment, this case was deemed reportable.

• Brand Name: FIVE S 3.5X65, STERILE, FOR SINGLE USE,
• Type of Device: FIVE S, LARYNGOSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17117787
• MDR Text Key: 317064330
• Report Number: 2020550-2023-00128
• Device Sequence Number: 1
• Product Code: CAL
• UDI-Device Identifier: 04048551422519
• UDI-Public: 4048551422519
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2023

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
• Device Operator: Health Professional
• Device Model Number: 091361-06
• Device Catalogue Number: 091361-06
• Device Lot Number: 100080554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/12/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention