MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEX. INTUBATION VIDEO ENDOSCOPE 5.5X65; FLEXIBLE VIDEO INTUBATION LARYNGOSCOPE, REUSABLE

Model Number	11301BNX
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device failed during use.Upon insertion into the patient's trachea, the image was lost on the c-mac monitor.Upon withdrawal, the image returned.But then the same failure occurred again.Or stuff needs to source an alternative scope to use.This added an extended period to the procedure, apparently turning a procedure that should have lasted approximately thirty minutes into one that lasted an hour and a half.No information about patient harm and the hazard so far.
Additional 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).
Additional Manufacturer Narrative
Investigation revealed that a piece of the membrane frame is broken off and the pressure dome main body shows missing pressure transmitting holes.According to the information received by legal manufacturer a wrong component was used to build the device during manufacturing process.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The complaint product was received on 2023-03-02 and was therefore available for investigation.Visual and microscopical examination revealed that shaft of the device was squeezed and the cover loosened from base near the distal tip.In addition a cut to the angulation cover, a leaky working channel and a vertebrae movement (deflection) was found.This will cause a image fail when activating the distraction.The device product history records have been checked for the available lot number no abnormalities were found.On the basis of the available information as well as the investigation results the error described by the customer can be confirmed.The root cause for the image failure during angulation of the video-endoscope is most likely due to a defective flexprint (loose contact).The defective flexprint which runs in the shaft is a consequential damage of the damages to the shaft.There is no indication for a material-, manufacturing- or design-related failure.The root cause of the reported issue can be traced back to a usage-related failure due to wrong handling.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FLEX. INTUBATION VIDEO ENDOSCOPE 5.5X65
• Common Device Name: FLEXIBLE VIDEO INTUBATION LARYNGOSCOPE, REUSABLE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 16513702
• Report Number: 1221826-2023-00053
• Device Sequence Number: 6296783
• Product Code: CAL
• UDI-Device Identifier: 04048551314609
• UDI-Public: 4048551314609
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11301BNX
• Device Catalogue Number: 11301BNX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 03/29/2023; 06/05/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/05/2023; 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown