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  

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the et tube, but the picture went blurry and did not clear with suctioning.The patient started to desaturate.The scope was retracted, and the ventilation was initiated.The scope was checked for completeness, and it was discovered that the camera tip was absent.After the procedure, the tip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.

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).

Manufacturer Narrative

The kind and amount of damage (sharp deformation on shaft ~70mm from distal side, the shaft is deformed oval in entire length between ~35 - 300mm from distal side, vertebrae shows deformation under distal rubber joint vertebrae- shaft is loose and rotating freely.Vertebrae moved out form shaft ~1mm) found during investigation indicates that the endoscope has been exposed to inappropriate forces, ignoring the correct handling given in the ifu.The event is filed under internal karl storz complaint id: (b)(4).

• 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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 17117788
• MDR Text Key: 317115466
• Report Number: 9610617-2023-00128
• Device Sequence Number: 1
• Product Code: CAL
• UDI-Device Identifier: 04048551422519
• UDI-Public: 4048551422519
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention